Recipient: Siemens Medical Solutions USA, Inc..
Product: molecular imaging diagnostic equipment device(s
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received a response letter We have reviewed your response and concluded it is inadequate in relation to each of the noted violations, which include, but are not limited to, the following:
1. Your firm failed to establish and maintain adequate procedures to control design validation, including software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example:
a. Because you failed to follow your procedure, the acceptance criteria were not complete prior to the performance of validation activities. Specifically, [redacted] for ECAT scanners introduced an error in the scan start time used in the decay correction algorithm. This error was most pronounced in the TTTT/EEEE mode which was not tested during the validation of the software update.
You did not provide the newly-created acceptance criteria for future revisions to the software nor documentation to substantiate your claim of reevaluation of the hazard analysis for ECAT systems. You did not provide copies of the procedure [redacted]. Also, the response indicates the two risk analyses were performed, and complaint and risk analysis procedures were revised, but copies were not provided. Please provide these documents for our review.
4. Your firm failed to establish and maintain adequate procedures to identify action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example:
a. At least four complaints were received concerning PET/CT scans linked to the wrong patient. Complaint PC0000295 was entered into your firm’s complaint system on September 27, 2005; complaint PC0000636 was entered on June 12, 2006; complaint 070098 was reported to your firm on January 30, 2007; and, complaint 07-0663 was reported to your firm on June 11, 2007. The software bug has been corrected in devices distributed since July 2006, but neither a software fix nor user notification has been distributed to customers who have devices received prior to July 2006.
c. The corrective and preventive actions for ECAT PET scanner malfunctions caused by software deficiencies and the required Medical Device Reporting submissions did not include documented preventive actions considerations.
Regarding item a, you did not provide a copy of the reassessment of the risk analysis which was performed. Since your firm has two different risk mitigations for the same problem, you should provide documentation showing both choices (software fix and user notification) address the problem and are compliant with your current risk management procedures. You did not provide the finalized copies of the user notification letter, risk management procedure and complaint handling procedure. You also should provide the training documentation which assures affected personnel have been trained on the revised procedures and/or practices.
Regarding item c, you did not provide the newly-created acceptance criteria for future revisions to the software, and provide documentation to substantiate your claim of reevaluation of the hazard analysis for ECAT systems.
FDA Office: New Orleans District