FDA 483 - Advocate Lutheran General Hospital - January 11, 2016

The FDA Form 483 details multiple violations regarding medical device reporting (MDR) at a user facility. The facility failed to submit FDA Form 3500A or electronic equivalents for 10 patient deaths potentially linked to CRE-infected duodenoscopes and 39 confirmed CRE positive cases to the device manufacturer within 10 working days. Additionally, 4 of 7 mandatory reports filed in a redacted period were not sent to the FDA within the required timeframe, and these reports lacked the date the facility became aware of the event.

Nine events requiring mandatory reporting (e.g., life-threatening, hospitalization, required intervention) were submitted using the voluntary FDA Form 3500 instead of the mandatory 3500A. MDR event files lacked supporting documentation, containing only the 3500 or 3500A forms, and did not include deliberations or decision-making processes for reportability. Block F (user facility information) was omitted from all 7 mandatory reports submitted in a redacted period.

The facility's written MDR procedure (policy #: LGH-061-008) is deficient. It does not require documentation of all information used for reportability decisions (e.g., patient records, lab results) or systems for timely follow-up and FDA inspection access. Furthermore, the procedure lacks a standardized review process for reportability, specific timeframes for evaluation/reporting, record retention timeframes