BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 12018058 · Received June 17, 2021

    Report

    Report Number
    3002809144-2021-00384
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 28, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161507
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CALCIUM, LIST NUMBER (B)(4) ((B)(6) , GERMANY AS MANUFACTURING SITE) TO ARCHITECT C16000, LIST NUMBER (B)(4) (IRVING, TX (B)(4) MANUFACTURING SITE). MDR NUMBER 3016438761-2021-00235-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CALCIUM, LIST NUMBER (B)(4) ((B)(6) , GERMANY .

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: SID (B)(6) (TOO LONG IN LENGTH TO PUT IN FIELD). 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 A FALSELY DEPRESSED CALCIUM RESULT FOR A PATIENT WHEN USING THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2021: SID (B)(6) = INITIAL RESULT = 0.71 MMOL/L, REPEAT = 2.40 MMOL/L (C4 ANALYZER), REPEAT ON ANOTHER ANALYZER IN THE LAB (C3 ANALYZER) = 2.34 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916202 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-32 50855UN20 00380740161507

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C16K PRC MOD, 03L77-01, C1601197| ARC C16K PRC MOD, 03L77-01, C1601197