BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE (LDH)

    MDR report key: 14464073 · Received May 20, 2022

    Report

    Report Number
    3002809144-2022-00174
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 3, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740161460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 91126UN21, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. LABELING IS ADEQUATE INFORMATION FOR THE OPERATOR TO PREPARE SAMPLES FOR LDH ANALYSIS. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S ISSUE AS SAMPLE PREPARATION IS EXTENSIVELY COVERED IN THE INSTRUCTIONS FOR USE. LOG ANALYSIS SHOWS SAMPLE PREPARATION MAY BE THE MOST LIKELY CAUSE. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY WITH THE LDH REAGENT IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE (SN (B)(4) FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT (SN (B)(4) 295 U/L, REPEATED ON ANOTHER INSTRUMENT (SN (B)(4) 683 AND 979 U/L SAME SAMPLE REPEATED AGAIN ON (C1601491) 303 AND 314 U/L, REPEATED ON (SN (B)(4) 309 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540071 LACTATE DEHYDROGENASE (LDH) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 2P56-22 91126UN21 00380740161460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C16K PRC MOD, 03L77-01, (B)(6) | ARC C16K PRC MOD, 03L77-01, (B)(6)