BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDX LIPID PROFILE+GLUCOSE

    MDR report key: 9130543 · Received September 27, 2019

    Report

    Report Number
    2027969-2019-00526
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    February 27, 2017
    Report Date
    September 27, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE EVENT, THERE WAS NO INDICATION OF A REPORTABLE MALFUNCTION BASED ON INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4). ALERE (B)(4) UPDATED REPORTING DECISIONS AND CONDUCTED A RETROSPECTIVE REVIEW OF COMPLAINTS AGAINST THE UPDATED REPORTING DECISIONS. THIS MDR IS A RETROSPECTIVE FILING THAT WAS IDENTIFIED DURING THIS RETROSPECTIVE REVIEW ACTIVITY ASSOCIATED WITH AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED IN JANUARY 2019 AT ALERE (B)(4) (REFERENCE EIR (B)(4)). THE AWARENESS DATE IS BASED ON UPDATED REPORTING DECISIONS AND COMPLETION OF THE RETROSPECTIVE REVIEW ACTIVITY. THERE IS NO NEW OR INCREASED TREND BASED ON THIS RETROSPECTIVE REVIEW ACTIVITY. INVESTIGATION RESULTS FURTHER INVESTIGATION TO DETERMINE WHETHER THE METER FAILED TO MEET SPECIFICATIONS CANNOT BE PURSUED BECAUSE THE METER WAS NOT RETURNED. MANUFACTURING BATCH RECORD REVIEW FOR CASSETTE LOT 394210 FOUND NO NCS OR LERS; THIS LOT MET ALL FINAL RELEASE SPECIFICATIONS. NO ISSUES WITH ANALYTE RECOVERY WERE OBSERVED. THE CUSTOMER DID NOT INDICATE WHETHER MAC CONTROLS WERE TESTED ON THE METER. UNABLE TO DETERMINE IF THE METER IS PERFORMING TO SPECIFICATIONS. UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE VALUES OF TESTING FROM THE LDX COMPARED TO THE LABORATORY WERE DISCREPANT. LDX:TC= <100, HDL=38, TRG=233, LDL=NA, GLU=97, LAB:TC=137, HDL=29, TRG=151, LDL=78, GLU=248. THERE WAS NO REPORT OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924301 LDX LIPID PROFILE+GLUCOSE CHOL/LIPID ANALYZER JJE ALERE SAN DIEGO 10-991 394210

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR