BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDX V2 ANALYZER NORTH AMERICAN VERSION

    MDR report key: 17821846 · Received September 26, 2023

    Report

    Report Number
    2027969-2023-00088
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 12, 2023
    Report Date
    January 22, 2024
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JJE
    UDI-DI
    00810039380307
    PMA / PMN Number
    K120615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. REVIEW OF THE RISK DOCUMENTS FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. H6 - ADVERSE EVENT PROBLEM AND H10 - ADDITIONAL MFG NARRATIVE WERE UPDATED AS THE INVESTIGATION WAS COMPLETED.H6 - ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE WAS PREVIOUSLY SUBMITTED AS "A0714 UNINTENDED ELECTRICAL SHOCK" AND SHOULD HAVE BEEN SUBMITTED AS "A0704 SPARKING" AND "A040605 MATERIAL DEFORMATION: MATERIAL FRAYED". H3 OTHER TEXT : ALTHOUGH REQUESTED, THE CUSTOMER INDICATED THE POWER-SUPPLY WAS DISCARDED.

    Additional Manufacturer Narrative · 0

    RESULTS PENDING COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : ALTHOUGH REQUESTED, THE CUSTOMER INDICATED THE POWER-SUPPLY WAS DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVING SPARKS FROM THEIR FRAYED CHOLESTECH LDX ANALYZER POWER-SUPPLY DURING THE PERFORMANCE OF A HARD REBOOT. THE ANALYZER HAD NOT RECENTLY BEEN MOVED OR DROPPED AND THE ANALYZER WAS SET UP ON A DRY, STABLE SURFACE WITH NO OTHER INSTRUMENTS AROUND. TECHNICAL SERVICES ATTEMPTED TO GATHER ADDITIONAL INFORMATION ON THE LOCATION OF THE FRAY AND SPARK ON THE POWER SUPPLY, HOWEVER THE CUSTOMER COULD NOT PROVIDE ADDITIONAL DETAILS AND INDICATED THE POWER SUPPLY HAD BEEN DISCARDED. NO INJURY OR HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVING SPARKS FROM THEIR FRAYED CHOLESTECH LDX ANALYZER POWER-SUPPLY DURING THE PERFORMANCE OF A HARD REBOOT. THE ANALYZER HAD NOT RECENTLY BEEN MOVED OR DROPPED AND THE ANALYZER WAS SET UP ON A DRY, STABLE SURFACE WITH NO OTHER INSTRUMENTS AROUND. TECHNICAL SERVICES ATTEMPTED TO GATHER ADDITIONAL INFORMATION ON THE LOCATION OF THE FRAY AND SPARK ON THE POWER SUPPLY, HOWEVER THE CUSTOMER COULD NOT PROVIDE ADDITIONAL DETAILS AND INDICATED THE POWER SUPPLY HAD BEEN DISCARDED. NO INJURY OR HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440959 LDX V2 ANALYZER NORTH AMERICAN VERSION CHOLESTECH LDX ANALYZER JJE ALERE SAN DIEGO, INC. 14-874 00810039380307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown