BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C LACTATE DEHYDROGENASE REAGENT KIT

    MDR report key: 12882019 · Received November 29, 2021

    Report

    Report Number
    3002809144-2021-00676
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    November 15, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740130244
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW FOR LOT 24339UN21 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY C LACTATE DEHYDROGENASE REAGENT LOT 24339UN21 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE PROVIDED: 125 TO 220), UNITS OF MEASURE = U/L): (B)(6) 2021 SID (B)(6) INITIAL RESULT = 831, REPEATS = 286 AND 222. (B)(6) 2021 SID (B)(6) INITIAL RESULT = 201, REPEATS = 171, 157, AND 156. (B)(6) 2021 SID (B)(6) INITIAL RESULT = 268, REPEATS = 326 AND 313. THE RESULTS GENERATED WERE FROM AN AUTOMATIC 1:3 DILUTION THAT WAS PROGRAMED ON THE INSTRUMENT. THE SAMPLES WERE NOT RUN UNDILUTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE PROVIDED: 125 TO 220), UNITS OF MEASURE = U/L): (B)(6) 2021 SID (B)(6) INITIAL RESULT = 831, REPEATS = 286 AND 222 (B)(6) 2021 SID (B)(6) INITIAL RESULT = 201, REPEATS = 171, 157, AND 156 (B)(6) 2021 SID (B)(6) INITIAL RESULT = 268, REPEATS = 326 AND 313 THE RESULTS GENERATED WERE FROM AN AUTOMATIC 1:3 DILUTION THAT WAS PROGRAMED ON THE INSTRUMENT. THE SAMPLES WERE NOT RUN UNDILUTED. ADDITIONAL LABORATORY DATA WAS PROVIDED BY THE CUSTOMER: SID (B)(6): PLATELET COUNT = 800 SID (B)(6): PLATELET COUNT = 212 SID (B)(6): PLATELET COUNT = 559.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781541 ALINITY C LACTATE DEHYDROGENASE REAGENT KIT NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 07P7420 24339UN21 00380740130244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, (B)(6)| ALNTY C PROCESSING MODU, 03R67-01, (B)(6)