BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6-DRUG INTEGRATED CUP W/ADULT. STRIP

    MDR report key: 5895275 · Received August 22, 2016

    Report

    Report Number
    2027969-2016-00584
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Report Date
    July 26, 2016
    Product Code
    DIO
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH IN-HOUSE DRUG FREE DONOR URINE; ALL BZO, MET, COC, THC, AMP AND OPI RESULTS WERE NEGATIVE AT 5 MIN READ TIME AND MET QC SPECIFICATION. NO FALSE POSITIVE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN AN EMAIL PROVIDED BY THE CLIENT, THEY STATE THAT THEY ARE HAVING PRESUMPTIVE POSITIVE ICUPS, 6-DRUG INTEGRATED CUP W/ADULTERATION STRIP, FOR ALL THE DRUGS ON THE DEVICE AND ARE SENDING THE DONOR URINE IN FOR THE LAB TESTING AND GETTING NEGATIVE RESULTS. THE ANALYTES INCLUDED ARE: AMP (AMPHETAMINE); BZO (BENZODIAZEPINES); COC (COCAINE); MET (METHAMPHETAMINE); OPI (OPIATES); THC (TETRAHYDROCANNABINOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545984 6-DRUG INTEGRATED CUP W/ADULT. STRIP DRUG OF ABUSE TEST DIO DUA-167-022 DOA6010069

    Patients

    Seq Age Sex Outcome Treatment
    1