BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE METERPRO DOMESTIC KIT

    MDR report key: 5221896 · Received November 13, 2015

    Report

    Report Number
    2027969-2015-00928
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 16, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K973547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME: REMOVED TRIAGE TOX DRUG PANEL (25T), AS COMPLAINT DEVICE AND ADDED THE TRIAGE METERPRO DOMESTIC KIT (METER). MODEL #: REMOVED TOX PENAL NUMBER (94400EU) AND INCLUDED THE METER SERIAL # ((B)(4)). CONCOMITANT MEDICAL PRODUCTS: REMOVED THE METER AS THE CONCOMITANT MEDICAL PRODUCT AND INCLUDED THE TRIAGE TOX DRUG SCREEN PANEL. THE 510(K)#: REMOVED THE 510(K) # FOR THE TOX DRUG SCREEN PANEL AND INCLUDED THE ONE FOR THE METERPRO KIT ((B)(4)). LABELED FOR SINGLE USE: CHANGED FROM 'YES' TO 'NO' SINCE THE METER IS NOT A SINGLE USE DEVICE. USAGE OF DEVICE: CHANGED FROM 'UNKNOWN' TO 'REUSE' SINCE THE METER IS NOT A SINGLE USE DEVICE. MANUFACTURER NARRATIVE: CUSTOMER'S COMPLAINT OF FALSE POSITIVE RESULTS FOR ALL ANALYTES WAS REPLICATED WITH THE RETURNED METER ONLY. IN-HOUSE METERS DID NOT PRODUCE ERRONEOUS RESULTS WITH THE SAME DEVICES/PANELS TESTED ON THE RETURNED METER. ISSUE APPEARS TO BE RELATED TO THE RETURNED METER. REVIEWED THE BATCH RECORD FOR TOX LOT W60458RB; THE LOT PASSED OUS RELEASE SPECIFICATIONS. DURING THE INVESTIGATION, IT WAS FOUND THE RETURNED METER HAD INCORRECTLY SET ANALYTE THRESHOLD RANGES BY THE CUSTOMER'S DATA MANAGEMENT SOFTWARE. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS ISSUE. NO FURTHER INVESTIGATION WILL BE PURSUED. NO PRODUCT DEFICIENCY WAS ESTABLISHED WITH TOX LOT W60458; NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED POTENTIAL FALSE POSITIVE RESULTS ON ALL ANALYTES WHEN TESTING THE TRIAGE TOX DRUG SCREEN PANEL (25T). CUSTOMER REPORTED THAT THEY WERE SETTING UP A NEW TRIAGE METER AND RAN A KNOWN NEGATIVE SAMPLE (WATER) THAT GAVE POSITIVE RESULTS FOR ALL ANALYTES. WHILE TESTING THE METER, THE CUSTOMER SUSPECTED THAT THERE MAY BE SOMETHING IN THE SETTINGS CAUSING THE PROBLEM. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE US).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752741 TRIAGE METERPRO DOMESTIC KIT DOA DRUG SCREEN TEST DJR ALERE SAN DIEGO, INC. 55070 W60458R

    Patients

    Seq Age Sex Outcome Treatment
    1