BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    MDR report key: 7252986 · Received February 8, 2018

    Report

    Report Number
    1628664-2018-00056
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 21, 2018
    Report Date
    February 23, 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 · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, INSTRUMENT LOG REVIEW, AND A REVIEW OF LABELING. REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE WAS NORMAL COMPLAINT ACTIVITY FOR LIKELY CAUSE LOT 45139UN17. A REVIEW OF TRACKING AND TRENDING REPORTS DID NOT IDENTIFY ANY ADVERSE OR NON-STATISTICAL TRENDS FOR THE LACTATE DEHYDROGENASE (LDH) ASSAY. THE CUSTOMER INSTRUMENT LOGS WERE REVIEWED AND SHOWS THE INSTRUMENT TO BE WELL MAINTAINED. THE CUSTOMER LDH ASSAY PARAMETER FILE IS CORRECT AND THE CUSTOMER IS CONSISTENTLY USING THE 1:3 RECOMMENDED DILUTION PROTOCOL FOR PLASMA SAMPLES. EVIDENCE OF ASPIRATION RELATED ERRORS ON SAMPLES WAS NOTED WHICH SUGGESTS INCONSISTENT SAMPLE PROCESSING. THE REVIEW ALSO SHOWS THAT QUALITY CONTROL (QC) RESULTS, THREE LEVELS, DO NOT SHOW THE SAME INCONSISTENCY OF RESULTS. 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 CUSTOMERS ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT LACTATE DEHYDROGENASE ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED AND INCONSISTENT ARCHITECT LACTATE DEHYDROGENASE RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DISCREPANT RESULTS. SAMPLE ID (B)(6) GENERATED 226 AND 180 U/ML. SAMPLE ID (B)(6) GENERATED 262, 215 AND 178 U/ML. SAMPLE ID (B)(6) GENERATED 235 AND 208 U/ML. SAMPLE ID (B)(6) GENERATED 231 AND 213 U/ML. SAMPLE ID (B)(6) GENERATED 237 AND 202 U/ML. SAMPLE ID (B)(6) GENERATED 223 AND 218 U/ML. SAMPLE ID (B)(6) GENERATED 254, 241, 222 AND 216 U/ML. SAMPLE ID (B)(6) GENERATED 267, 250, 217 AND 179 U/ML. SAMPLE ID (B)(6) GENERATED 226, 202 AND 216 U/ML. SAMPLE ID (B)(6) GENERATED 232, 203 AND 202 U/ML. SAMPLE ID (B)(6) GENERATED 226 AND 188 U/ML. SAMPLE ID (B)(6) GENERATED 221 AND 188 U/ML. SAMPLE ID (B)(6) GENERATED 265 AND 165 U/ML. SAMPLE ID (B)(6) GENERATED 223 AND 202 U/ML. SAMPLE ID (B)(6) GENERATED 233 AND 215 U/ML. SAMPLE ID (B)(6) GENERATED 265, 252 AND 220 U/ML. SAMPLE ID (B)(6) GENERATED 229 AND 220 U/ML. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED AND NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100154 CLINICAL CHEMISTRY LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 45139UN17 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1