BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CALCIUM REAGENT KIT

    MDR report key: 12868247 · Received November 24, 2021

    Report

    Report Number
    3002809144-2021-00673
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 9, 2021
    Report Date
    January 4, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740135409
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT SUSPECTED MEDICAL DEVICE IS ALINITY C PROCESSING MODULE, MANUFACTURING SITE IS IRVING, TX, AND WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2022-00001-00. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER MDR NUMBER 3016438761-2022-00001-00.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CALCIUM RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 2.20-2.62 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT WAS (B)(6) , REPEATS WERE (B)(6) , (B)(6) , (B)(6) , (B)(6) , AND (B)(6) MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769532 ALINITY C CALCIUM REAGENT KIT AZO DYE, CALCIUM CJY ABBOTT GMBH 07P5730 46997UN21 00380740135409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC01380| ALNTY C PROCESSING MODU, 03R67-01, AC01380