BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 11763561 · Received May 3, 2021

    Report

    Report Number
    3002809144-2021-00284
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161491
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LOT NUMBER 06558UN20. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. FILE SAMPLE ANALYSIS WAS NOT PERFORMED AS RETESTING OF THE SAMPLES GAVE EXPECTED NORMAL RESULTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY CALCIUM REAGENT (LN 3L79) LOT NUMBER 06558UN20 WAS IDENTIFIED. THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 INSTRUMENT FOR ONE PATIENT. SID (B)(4) GENERATED CALCIUM RESULTS OF 44 / 90 / 92 MG/L; (CUSTOMER REFERENCE RANGE 84 MG/L TO 102 MG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661124 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-22 06558UN20 00380740161491

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C16K REFURB-SEKAT, 03L77-97, (B)(4)| ARC C16K REFURB-SEKAT, 03L77-97, (B)(4)