BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 14655467 · Received June 10, 2022

    Report

    Report Number
    3002809144-2022-00200
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161507
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORDS FOR ARCHITECT CALCIUM REAGENT, LOT NUMBER 10783UN21. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. USER ERROR MAY HAVE CONTRIBUTED TO THE ISSUE AS THE INSTRUMENT LOGS SHOWED ASPIRATION ERRORS FOR THE SUSPECT SAMPLE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CALCIUM REAGENT, LOT NUMBER 10783UN21 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID D22275390Q=1.46 MMOL/L /REPEATED=2.29 MMOL/L /REPEATED ON ARCHITECT C1601335=2.32 MMOL/L LABORATORY REFERENCE RANGE FOR CALCIUM=2.20 TO 2.26 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155575 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-32 10783UN21 00380740161507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C16K REFURB-SEKAT, 03L77-97, C1600062| ARC C16K REFURB-SEKAT, 03L77-97, C1600062