BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    MDR report key: 3062082 · Received April 16, 2013

    Report

    Report Number
    1628664-2013-00099
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JIX
    PMA / PMN Number
    K981706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LIST 08G62-20, LOT 43016UQ09 MANUFACTURED AT ABBOTT MANUFACTURING, IRVING TEXAS TO CLINICAL CHEMISTRY TOTAL BILIRUBIN LIST 06L45-21, UNKNOWN LOT NUMBER, ALSO MANUFACTURED AT ABBOTT MANUFACTURING, (B)(4). MDR 1628664-2013-00110 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED IN THAT MDR. NOTE IN THE PREVIOUS FOLLOW UP THE INCORRECT MDR NUMBER WAS REFERENCED. INCORRECT: 1628664-2013-00001, CORRECT: 1628664-2013-00110. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LIST 08G62-20 LOT 43016UQ09 MANUFACTURED AT ABBOTT MANUFACTURING, (B)(4) TO CLINICAL CHEMISTRY TOTAL BILIRUBIN LIST 06L45-21, UNKNOWN LOT NUMBER, ALSO MANUFACTURED AT ABBOTT MANUFACTURING, IRVING TEXAS. MDR 1628664-2013-00001 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED IN THAT MDR. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED (B)(6) TOTAL BILIRUBIN RESULTS FOR ONE PATIENT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: 18 MG/DL (REPORTED OUT), 16 MG/DL (RAN THE DAY BEFORE AND THE PHYSICIAN QUESTIONED IT). THE SAMPLE WAS SENT TO A SISTER LAB: INITIAL 14 MG/DL, AND REPEATED 3 DAYS LATER (AND IT HAD BEEN FROZEN) 13 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162724 CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR JIX ABBOTT MANUFACTURING INC 43016UQ09

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 02P24-40, SN (B)(4)| LN 02P24-40, SN (B)(4)| ARCHITECT C4000 ANALYZER:| ARCHITECT C4000 ANALYZER:| ARCHITECT C4000 ANALYZER:| LN 02P24-40, SN (B)(4)