ADIMS 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860007397615), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2022Application Program Problem

  THE REQUIREMENT TO HAVE ONE-YEAR POST COLLECTION NEGATIVE TEST RESULTS WAS INCLUDED IN THE USER REQUIREMENT SPECIFICATIONS; BUT WAS NOT PROGRAMMED AS INTENDED IN THE APPLICATION. THE REQUIREMENT TO MARK ANY ALIQUOT WITH POSITIVE TEST RESULTS FOR DESTRUCTION IS PROGRAMMED AS INTENDED. TO THIS DATE, THERE HAVE BEEN NO POSITIVE ALIQUOTS THAT REQUIRE DESTRUCTION. A TOTAL OF 54 ALIQUOTS WERE IMPACTED. ALL ALIQUOTS HAD ACCEPTABLE TEST RESULTS AT TIME OF COLLECTION. ONE (1) YEAR POST DONATION TEST RESULTS WERE NOT AVAILABLE AT TIME OF DEGLYCEROLIZATION. EIGHT (8) ALIQUOTS WERE ADMINISTERED WITHOUT TESTING AT THE TIME OF ADMINISTRATION; BUT RECEIVED ACCEPTABLE TEST RESULTS AFTERWARDS; 46 ALIQUOTS FROM 7 DIFFERENT DONORS WERE ADMINISTERED WITH NO 1 YEAR POST DONATION TESTING RECEIVED TO DATE, BUT HAD ACCEPTABLE RESULTS AT THE TIME OF COLLECTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416908 ↗