BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 14250500 · Received April 29, 2022

    Report

    Report Number
    3002809144-2022-00145
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 10, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161491
    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

    SID: 1000812: (B)(6). SID 10800712A: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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 REVIEW. RETURN TESTING WAS NOT COMPLETE AS RETURNS WERE NOT AVAILABLE. A SEARCH FOR SIMILAR TICKETS DID NOT REVEAL AN INCREASE IN COMPLAINT ACTIVITY. THE TREND REVIEW FOUND NO TRENDS RELATED TO THIS ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE CURRENT COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CALCIUM REAGENT LOT 10782UN21 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT CALCIUM RESULTS GENERATED ON AN ARCHITECT C4000 ANALYZER FOR TWO PATIENTS WHEN COMPARED TO RESULTS GENERATED ON ANOTHER ANALYZER. THE CUSTOMER PROVIDED REFERENCE RANGE IS 6.3-11.9 MG/DL. SID: (B)(4) INITIAL RESULT = 6.7 MG/DL, REPEAT =6.6 MG/DL, REPEAT ON ANOTHER ANALYZER = 6.0 MG/DL. SID (B)(4) INITIAL RESULT = 3.0 MG/DL, REPEAT RESULT = 3.1 MG/DL, REPEAT RESULT ON ANOTHER ANALYZER = 7.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212764 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-22 10782UN21 00380740161491

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C4000 INTGR, 02P24-40, C400707.| ARC C4000 INTGR, 02P24-40, C400707.