BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE CHOLESTECH LDX ANALYZER (POWER SUPPLY)

    MDR report key: 11282361 · Received February 4, 2021

    Report

    Report Number
    2027969-2021-00010
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Report Date
    February 4, 2021
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JJE
    PMA / PMN Number
    K120615
    Removal / Correction Number
    2027969-02/14/19-0001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    POWER SUPPLY LOT (1837D) WAS ASSOCIATED WITH FIELD ACTION 2027969-02/14/19-001-C FOR A DEFECTIVE POWER SUPPLY. THE DEFECTIVE POWER SUPPLY RESULTS IN AN INABILITY TO POWER ON THE LDX ANALYZER. NO FURTHER INVESTIGATION WILL BE PURSUED UNDER THIS CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS POWER ISSUE ON LDX. POWER CORDS ARE NOT VISIBLY DAMAGED. NO BURNING, NO MELTING, NO SMOKING, NO INJURY. ISSUE WAS RESOLVED WITH AN ALTERNATE LDX POWER CORD. THREE LDX POWER SUPPLIES WERE RECEIVED BY THE INVESTIGATOR ON 1 FEB 2021 AND IT WAS CONFIRMED THE POWER SUPPLIES HAD IDENTIFIER CODE 1837D, WHICH WERE PART OF THE LDX POWER SUPPLY RECALL. NO ADVERSE OUTCOMES REPORTED. THERE WERE THREE LDX ANALYZERS CORRESPONDING WITH THREE AFFECTED LDX POWER SUPPLIES. PLEASE SEE MDRS 2027969-2021-00009 AND 2027969-2021-00011 FOR THE ALTERNATE LDX ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178135 ALERE CHOLESTECH LDX ANALYZER (POWER SUPPLY) CHOLESTEROL/LIPIDS ANALYZER JJE ALERE SAN DIEGO, INC. 14-874

    Patients

    Seq Age Sex Outcome Treatment
    1