Automated Blood Coagulation Analyzer CS-5100 BY990757Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987562425426), received between Jun 15, 2018 and Oct 5, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2023Leak/Splash; Leak/Splash

  THE USER IDENTIFIED LIQUID ON THE FLOOR NEAR THE ANALYZER WASTE DRAWER AND OPENED THE DRAWER TO INVESTIGATE. THE ANALYZER WASTE TUBING WAS DISCONNECTED FROM THE WASTE JUG CONNECTION NIPPLE, CAUSING A LIQUID SPRAY. THE USER WAS SPRAYED IN THE FACE BY THE ANALYZER WASTE LIQUID AND WAS PRESCRIBED WITH AN HIV MEDICATION FOR 28 DAYS.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882272 ↗
• InjuryDec 14, 2022Low Test Results; Low Test Results

  THE OPERATOR REPORTED A FALSELY DECREASED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TO THE MEDICAL TEAM. THE PATIENT RECEIVED UNNECESSARY HEPARIN TREATMENT BASED ON THE ERRONEOUS RESULT. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED DUE TO THE UNNECESSARY HEPARIN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977415 ↗
• InjurySep 1, 2020Use of Device Problem; Use of Device Problem

  THE PATIENT RECEIVED AN UNNECESSARY CRYOPRECIPITATE TRANSFUSION DUE TO FLAGGED FIBRINOGEN (FBG) RESULTS THAT WERE INCORRECTLY REPORTED TO THE MEDICAL TEAM. ONE PATIENT SAMPLE WAS ANALYZED FOR FBG. THE ANALYZER GENERATED "NO COAGULATION", "SLIGHT COAGULATION" AND "DEFECTIVE SAMPLE VOLUME" ERRORS. THE RESULTS WERE SUPPRESSED RESULTS [***.*]. THE OPERATOR REPORTED FBG < 50 MG/DL. THE PHYSICIAN ADMINISTERED CRYOPRECIPITATE. THE CORRECT FBG VALUE IS UNKNOWN. IT IS UNKNOWN IF CORRECTED REPORTS WERE ISSUED. NO HARM WAS REPORTED DUE TO THE UNNECESSARY TRANSFUSIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10478328 ↗
• InjurySep 1, 2020Use of Device Problem; Use of Device Problem

  THE PATIENT RECEIVED AN UNNECESSARY CRYOPRECIPITATE TRANSFUSION DUE TO FLAGGED FIBRINOGEN (FBG) RESULTS THAT WERE INCORRECTLY REPORTED TO THE MEDICAL TEAM. MULTIPLE SAMPLES FROM ONE PATIENT WERE ANALYZED FOR FIBRINOGEN (FBG) OVER THE COURSE OF TWO DAYS. THE ANALYZER GENERATED "NO COAGULATION" AND "SLIGHT COAGULATION" ERRORS. THE RESULTS WERE DISPLAYED WITH ASTERISKS [*] OR AS SUPPRESSED RESULTS [***.*]. THE OPERATOR REPORTED FBG < 50 MG/DL. THE PHYSICIAN ADMINISTERED CRYOPRECIPITATE. A CORRECTED REPORT WAS ISSUED. NO HARM WAS REPORTED DUE TO THE UNNECESSARY TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10477624 ↗
• InjurySep 1, 2020Use of Device Problem; Use of Device Problem

  THE PATIENT RECEIVED UNNECESSARY CRYOPRECIPITATE AND FRESH FROZEN PLASMA TRANSFUSIONS DUE TO FLAGGED FIBRINOGEN (FBG) RESULTS THAT WERE INCORRECTLY REPORTED TO THE MEDICAL TEAM. MULTIPLE SAMPLES FROM ONE PATIENT WERE ANALYZED FOR FBG OVER THE COURSE OF FIVE DAYS. THE ANALYZER GENERATED "NO COAGULATION" AND "SLIGHT COAGULATION" ERRORS. THE RESULTS WERE DISPLAYED WITH ASTERISKS [*] OR AS SUPPRESSED RESULTS [***.*]. THE OPERATOR REPORTED FBG < 50 MG/DL. THE PHYSICIAN ADMINISTERED CRYOPRECIPITATE 14 TIMES AND FRESH FROZEN PLASMA 6 TIMES. THE CORRECT FBG VALUES ARE UNKNOWN. IT IS UNKNOWN IF CORRECTED REPORTS WERE ISSUED. NO HARM WAS REPORTED DUE TO THE UNNECESSARY TRANSFUSIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10477540 ↗
• MalfunctionJun 15, 2018Thermal Decomposition of Device; Charred; Thermal Decomposition of Device; Charred

  A USER IN (B)(6) REPORTED OBSERVING SMOKE COMING FROM THE ANALYZER AND IMMEDIATELY TURNED OFF THE ANALYZER. NO USER HARM AND NO NEGATIVE PATIENT IMPACT WAS REPORTED DUE TO THIS EVENT. THE SERVICE ENGINEER CONFIRMED THAT THE SMOKE WAS FROM CHARRED COMPONENTS SEEN ON THE PRINTED CIRCUIT BOARD (PCB). THE PCB IS LOCATED UNDER THE RIGHT SIDE PANEL IN THE UPPER REAR CORNER OF THE INSTRUMENT. THE ANALYZER WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606056 ↗