BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIRUBIN TOTAL GEN. 3

    MDR report key: 4099825 · Received September 18, 2014

    Report

    Report Number
    1823260-2014-07138
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    June 11, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIG
    PMA / PMN Number
    K131544
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD A RESULT MISMATCH FOR SAMPLES FROM THE SAME PATIENT THAT WERE TESTED BETWEEN AN OLDER GENERATION BILIRUBIN TOTAL REAGENT (BILT) AND BILIRUBIN TOTAL GEN.3 (BILT3). THE PATIENT WAS BORN IN 1971 AND HAS MULTIPLE MYELOMA. HE WAS BEING TREATED BY CHEMOTHERAPY AND DIVERSE PSYCHIATRIC MEDICATIONS AT THE TIME OF THE EVENT. THREE DIFFERENT SAMPLES FROM THIS PATIENT HAD ERRONEOUS RESULTS. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 0.26 MG/DL FOR BILT AND 4.40 MG/DL FOR BILT3 WHEN TESTED ON A PPE MODULAR SYSTEM. THE SECOND SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 5.86 MG/DL FOR BILT3 WHEN TESTED ON A PPE MODULAR SYSTEM. THIS SAMPLE WAS ALSO REPEATED ON AN INTEGRA 400 SYSTEM AND RESULTED AS <0.0 MG/DL ACCOMPANIED BY A DATA FLAG FOR BILT3. THIS SAMPLE COULD NOT BE RETESTED SINCE THERE WAS NOT ENOUGH SERUM. THE THIRD SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 1.3 MG/DL FOR BILT3 WHEN TESTED ON AN INTEGRA 400 SYSTEM. THE SAMPLE WAS REPEATED ON A PPE MODULAR SYSTEM AND RESULTED AS 0.26 MG/DL FOR BILT AND 5.86 MG/DL FOR BILT3. THE SAMPLE WAS AUTOMATICALLY REPEATED ON THE PPE MODULAR SYSTEM AND RESULTED AS 0.19 MG/DL FOR BILT AND 2.98 MG/DL FOR BILT3. THE SAMPLE WAS ALSO REPEATED ON A PE MODULAR SYSTEM, RESULTING AS 5.88 MG/DL FOR BILT3. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE PPE MODULAR SYSTEM SERIAL NUMBER IS (B)(4). THE INTEGRA 400 SYSTEM SERIAL NUMBER IS (B)(4). THE PE MODULAR SYSTEM SERIAL NUMBER IS (B)(4). A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. BASED UPON THE INFORMATION PROVIDED, THE ERRONEOUS RESULTS MAY HAVE BEEN DUE TO THE PATIENT'S MULTIPLE MYELOMA AND OR GAMMOPATHY. THE PACKAGE INSERT DOCUMENTS THIS LIMITATION. IN ADDITION, THE PATIENT RECEIVED A SERIES OF MEDICATIONS, WHICH MAY HAVE INTERFERED WITH THE BILT3 RESULTS. THE NAMES OF THE MEDICATIONS WERE REQUESTED, BUT NOT PROVIDED. THE POSSIBLE DRUG INTERFERENCE COULD NOT BE FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579819 BILIRUBIN TOTAL GEN. 3 DIAZO COLORIMETRY, BILIRUBIN CIG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1