BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL BILIRUBIN

    MDR report key: 15973138 · Received December 13, 2022

    Report

    Report Number
    3002809144-2022-00436
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 25, 2022
    Report Date
    December 18, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CIG
    UDI-DI
    00380740174965
    PMA / PMN Number
    K121985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ARCHITECT C16000, LIST 3L77 (IRVING, TX AS MANUFACTURING SITE) AND SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2022-00592. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER MDR NUMBER 3016438761-2022-00592.AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ARCHITECT C16000, LIST 3L77 (IRVING, TX AS MANUFACTURING SITE) AND SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2022-00592. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER MDR NUMBER 3016438761-2022-00592.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS ON 4 SAMPLES THAT REPEATED LOWER WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES A REFERENCE RANGE OF 3.4 TO 20.5 UMOL/L. SID (B)(6) (FEMALE, 32 YEAR OLD, HAN/CHINESE) TESTED 1.7 REPEATED 7.2 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 1.40 REPEATED 12.4 UMOL/L. SID (B)(6) (FEMALE, 28 YEAR OLD, HAN/CHINESE) TESTED 3.1 REPEATED 8.1 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 0.8 REPEATED 7.2 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS ON 4 SAMPLES THAT REPEATED LOWER WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES A REFERENCE RANGE OF 3.4 TO 20.5 UMOL/L. SID (B)(6) (FEMALE, 32 YEAR OLD, HAN/CHINESE) TESTED 1.7 REPEATED 7.2 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 1.40 REPEATED 12.4 UMOL/L. SID (B)(6) (FEMALE, 28 YEAR OLD, HAN/CHINESE) TESTED 3.1 REPEATED 8.1 UMOL/L. SID (B)(4) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 0.8 REPEATED 7.2 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996111 TOTAL BILIRUBIN DIAZO COLORIMETRY, BILIRUBIN CIG ABBOTT GMBH 6L45-22 00380740174965

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ARC C16K PRC MOD, 03L77-01, (B)(6) | ARC C16K PRC MOD, 03L77-01, (B)(6)