Multifibren® U 10446691Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768017872), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (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.

• MalfunctionApr 4, 2019High Test Results; High Test Results

  THREE DISCORDANT, FALSELY ELEVATED FIBRINOGEN RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES USING MULTIFIBREN U REAGENT ON AN ATELLICA COAG 360 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO OF THE THREE SAMPLES WERE REPEATED USING THE FIB MULTI U LOW METHOD WITH THE SAME MULTIFIBREN U REAGENT ON THE SAME ATELLICA COAG 360 SYSTEM, RESULTING LOWER. THE SAME THREE SAMPLES WERE REPEATED AT ANOTHER LABORATORY ON A SYSMEX CS-5100 SYSTEM USING DADE THROMBIN REAGENT, ALSO RESULTING LOWER. THE CUSTOMER DID NOT INDICATE IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FIBRINOGEN RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482833 ↗