BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE METER PRO

    MDR report key: 6491450 · Received April 13, 2017

    Report

    Report Number
    2027969-2017-00066
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 16, 2017
    Report Date
    May 25, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    KHO
    PMA / PMN Number
    K973547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH THE RETURNED METER. NO EVIDENCE OF CHARRING OR BURNING WAS OBSERVED ON THE POWER SUPPLY OR METER. THE METER POWERED ON SUCCESSFULLY AND THE QCD PASSED. UNABLE TO DETERMINE A ROOT CAUSE OF THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TRIAGE METER PRO POWER CORD BURNT THROUGH AFTER A POWER OUTAGE AT THE FACILITY. THERE WAS NO PATIENT OR USER INJURY. THE TRIAGE METER PRO WAS DAMAGED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270862 TRIAGE METER PRO FLUOROMETER, FOR CLINICAL USE KHO ALERE SAN DIEGO, INC. 55071 72419

    Patients

    Seq Age Sex Outcome Treatment
    1 METER POWER CORD, PN 52059