BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY TOTAL BILIRUBIN

    MDR report key: 3083788 · Received April 29, 2013

    Report

    Report Number
    1628664-2013-00110
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THE CUSTOMER INDICATED THAT THEY WERE USING LOT NUMBERS 43052UQ11 AND 43015UQ09 OF LIST 06L45-21 (CLINICAL CHEMISTRY TOTAL BILIRUBIN) DURING THE TIMEFRAME OF THE EVENT. IT IS UNKNOWN WHICH LOT GENERATED THE DISCREPANT RESULT. THIS ISSUE WAS PREVIOUSLY SUBMITTED UNDER A DIFFERENT LIKELY CAUSE MDR 1628664-2013-00099. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER'S ISSUE INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND IN-HOUSE FILE SAMPLE TESTING. SIMILAR COMPLAINTS WERE REVIEWED AND NO PRODUCT ISSUES WERE IDENTIFIED. A REVIEW OF LABELING CONCLUDED THE ARCHITECT SYSTEM OPERATIONS MANUAL, UNDER OPERATIONAL PRECAUTIONS AND LIMITATIONS (SECTION 7, LIMITATIONS OF RESULT INTERPRETATION), PROVIDES GUIDANCE FOR ASSAY RESULTS IN REGARDS TO SYMPTOMS, OTHER TEST RESULTS, CLINICAL IMPRESSIONS AND OTHER DIAGNOSTIC PROCEDURES THAT MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT, AND LABELING IS ADEQUATE. FINALLY, THE PERFORMANCE WAS INVESTIGATED AND IN-HOUSE TESTING DEMONSTRATED THIS PRODUCT WAS PERFORMING WITHIN THE SPECIFICATIONS. COMPLAINT INFORMATION REASONABLY SUGGESTS THAT THE ASSAY IS PERFORMING AS INTENDED AND NO MALFUNCTION OF THE DEVICE OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO BILIRUBIN CALIBRATOR, LN 1E66, LOT 13429M500 PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED NEONATAL TOTAL BILIRUBIN RESULTS FOR ONE PATIENT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: 23.3 MG/DL (ON REAGENT LOT 43052UQ11), 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 (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
    185449 CLINICAL CHEMISTRY TOTAL BILIRUBIN CIG ABBOTT MANUFACTURING INC UNKNOWN

    Patients

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