BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM LDH

    MDR report key: 7263408 · Received February 12, 2018

    Report

    Report Number
    1628664-2018-00059
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 18, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CFJ
    UDI-DI
    00380740004033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR COMPLAINTS AGAINST LDH REAGENT LOT 45139UN17 WAS PERFORMED AND ONE ADDITIONAL COMPLAINT WAS FOUND, BUT NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT RESULT LOG WAS REVIEWED AND OVERALL THE LDH RESULTS REVIEWED ARE CONSISTENT WITH THE CUSTOMER COMPLAINT ISSUE. THE LOG REVIEW ALSO SHOWS THAT QUALITY CONTROL (QC) RESULTS DO NOT SHOW THE SAME INCONSISTENCY. THE QC SHOWS CONSISTENT RECOVERY OF EXPECTED LDH VALUES OVER ALL THREE LEVELS. SINCE QC SAMPLES ARE ASPIRATED, PROCESSED, AND MEASURED IN THE SAME WAY AS PATIENT SAMPLES, BUT DO NOT SHOW THE SAME ERRATIC RESULTS, THIS SUGGESTS THERE IS AN ISSUE WITH THE MANNER THE PATIENT SAMPLE IS TREATED PRIOR TO THE ANALYTICAL PHASE. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR CLIN CHEM LDH, LIST NUMBER 2P56-21, LOT NUMBER 46139UN17.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION. PATIENT INFORMATION. PATIENT IDENTIFIER - MULTIPLE = (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED/ERRATIC LDH RESULTS GENERATED ON THE ARCHITECT ANALYZER ON 10 PATIENTS. THE DISCREPANT RESULTS PROVIDED WERE: (B)(6) = 262U/L / 178 / 215; (B)(6) =237 / 301 / 256; (B)(6) =235 / 208; (B)(6) 213 / 231; (B)(6) = 222UL / 254 / 216 / 241; (B)(6) = 250 / 179 / 217 / 267; (B)(6) = 165 / 265; (B)(6) =233 / 215; (B)(6) = 220 / 265 / 252; (B)(6) = 180 / 226. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106715 CLIN CHEM LDH LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 45139UN17 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 SYSTEM, LIST # 03L77-01,| ARCHITECT C16000 SYSTEM, LIST # 03L77-01,| SERIAL # (B)(4)| SERIAL # (B)(4)