BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C LACTATE DEHYDROGENASE REAGENT KIT

    MDR report key: 14492296 · Received May 24, 2022

    Report

    Report Number
    3002809144-2022-00178
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740130244
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C LACTATE DEHYDROGENASE REAGENT KIT, LIST NUMBER 07P74-20, AND MANUFACTURING SITE WIESBADEN TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, AND MANUFACTURING SITE OF IRVING. MDR NUMBER 3016438761-2022-00262-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 731 U/L, REPEATED 215 AND 202 U/L (NORMAL RANGE 125 TO 220 U/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202972 ALINITY C LACTATE DEHYDROGENASE REAGENT KIT NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 07P7420 16138UN21 00380740130244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC04256.| ALNTY C PROCESSING MODU, 03R67-01, AC04256.