BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 12861602 · Received November 23, 2021

    Report

    Report Number
    3002809144-2021-00670
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161507
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. A REVIEW OF TICKETS BY PRODUCT LOT NUMBER COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. ALTHOUGH AN INCREASE IN COMPLAINT ACTIVITY WAS FOUND ASSOCIATED WITH THE CALCIUM REAGENT FOR FALSELY ELEVATED AND SHIFTS IN CALCIUM QUALITY CONTROL AND/OR PATIENT RESULTS THAT ARE DUE TO LOT TO LOT VARIABILITY AND NOT RELATED TO THIS CURRENT COMPLAINT ISSUE, WHICH IS SPECIFIC TO THE DOCUMENTED PATIENT SAMPLE. ADDITIONALLY, THE SAMPLE WHEN RETESTED, GENERATED A LOWER NORMAL RESULT AND QUALITY CONTROL WAS IN RANGE. ALSO, THE CUSTOMER RAN A PRECISION RUN WITH 10 REPLICATES OF QUALITY CONTROL WHICH WERE ALL WITHIN RANGE, INDICATING THE ASSAY IS PERFORMING AS EXPECTED. PRECISION STUDY WHEN PERFORMED USING QUALITY CONTROL MATERIAL WAS LESS THAN 3% WHICH WAS WITHIN THE ASSAY CLAIM. SAMPLES WERE REPEATED FROM THE SAME DAY THAT THE DISCREPANT SAMPLE WAS RUN AND NO DISCREPANT RESULTS WERE OBSERVED FOR OTHER SAMPLES. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE FOR LIST NUMBER 3L79. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CALCIUM REAGENT WITH AN UNKNOWN LOT NUMBER WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER FOR ONE SAMPLE THAT THE PHYSICIAN QUESTIONED. THE FOLLOWING DATA WAS PROVIDED (THE CUSTOMER¿S REFERENCE RANGE IS 8.5 TO 10.5 MG/DL): (B)(6) 2021 SID (B)(6) INITIAL RESULT = (B)(6) MG/DL, REPEAT = (B)(6) MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759837 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-32 00380740161507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C4000 INTGR, 02P24-40, C400690