Berichrom® Protein C 10446499Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768011900), received between Dec 21, 2018 and Dec 21, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FLAGGED NON-NUMERICAL PROTEIN C RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM, USING THE BERICHROM PROTEIN C REAGENT. THE FLAGGED RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF THE FLAGGED RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE DILUTED IN A 1:4 DILUTION AND REPEATED ON THE SAME SYSTEM, USING THE SAME REAGENT LOT, RESULTING IN NUMERICAL PROTEIN C RESULTS. THE REPEAT RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). ON (B)(6) 2018, SAMPLE ID (B)(6) WAS REPEATED AGAIN ON THE SAME SYSTEM AND REAGENT LOT, RESULTING HIGHER THAN THE REPEAT RESULT. THE CORRECT RESULT FOR EITHER PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT PROTEIN C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189356 ↗
• MalfunctionDec 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FLAGGED NON-NUMERICAL PROTEIN C RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM, USING THE BERICHROM PROTEIN C REAGENT. THE FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS DILUTED IN A 1:4 DILUTION AND REPEATED ON THE SAME SYSTEM, USING THE SAME REAGENT LOT, RESULTING IN A NUMERICAL PROTEIN C RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). ON (B)(6) 2018, THE SAMPLE WAS REPEATED AGAIN ON THE SAME SYSTEM AND REAGENT LOT, RESULTING HIGHER THAN THE REPEAT RESULT. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT PROTEIN C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189353 ↗