BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERICHROM PROTEIN C

    MDR report key: 8189356 · Received December 21, 2018

    Report

    Report Number
    9610806-2018-00116
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 21, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    00842768011900
    PMA / PMN Number
    K890634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT DIFFERENT PROTEIN C RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES USING THE BERICHROM PROTEIN C REAGENT. SIEMENS REVIEWED THE SYSMEX CS-5100 SYSTEM BACK UP FILES AND DETERMINED THAT THE CUSTOMER IS NOT USING THE MOST RECENT BERICHROM PROTEIN C APPLICATION ON THE SYSMEX CS-5100 SYSTEM. THE SOFTWARE APPLICATION USED BY THE CUSTOMER MAY NOT FEATURE RE-DILUTION AND IT IS POSSIBLE THAT THE CUSTOMER MANUALLY DILUTED THE SAMPLES PRIOR TO REPEATING THE SAMPLES. THERE IS NO INDICATION OF A SOFTWARE OR REAGENT MALFUNCTION AND SIEMENS DETERMINED THAT AN ISSUE WITH THE MANUAL DILUTION OF THE SAMPLES POTENTIALLY CONTRIBUTED TO THE DIFFERENT PROTEIN C RESULTS. THE SYSMEX CS-5100 SYSTEM INSTRUCTIONS FOR USE INDICATES THAT WHEN RESULTS ARE FLAGGED WITH ERROR CODE 0000.4000.0041 [EXTRAPOLATION BOUNDARY OVER (UPPER)], THE OPERATOR SHOULD CHANGE THE DILUTION RATIO AND REPEAT THE ANALYSIS. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2018-00117 WAS FILED FOR THE RESULT OBTAINED ON (B)(6) 2018 FOR SAMPLE ID (B)(6).

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028565 BERICHROM PROTEIN C BERICHROM PROTEIN C GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM PROTEIN C 48671 00842768011900

    Patients

    Seq Age Sex Outcome Treatment
    1