BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DRUG 6 PANEL CUP

    MDR report key: 4542728 · Received February 24, 2015

    Report

    Report Number
    2027969-2015-00137
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    January 30, 2015
    Report Date
    January 30, 2015
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD
    Product Code
    LDJ
    PMA / PMN Number
    K050878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION AND RETURN DEVICES. RETENTION (N=29) AND RETURN (N=7) PRODUCTS WERE TESTED WITH IN-HOUSE DRUG FREE DONOR URINE, ALL COC RESULTS WERE NEGATIVE AT READ TIME. NO COC FALSE POSITIVE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE COCAINE RESULTS. RESULTS AS FOLLOWS: CLIENT STATES THAT THE ICUP DEVICE HAD ONE FALSE PRESUMPTIVE POSITIVE RESULT FOR COC ON DONOR URINE SPECIMEN. THE CLIENT STATES THAT NO LINE APPEARED IN THE TESTING REGION FOR COC AT THE FIVE MINUTE READ TIME. THE DONOR THEN WAS SENT TO ANOTHER FACILITY TO PRODUCE A SALIVA SPECIMEN; RESULT WAS NEGATIVE. THE SALIVA WAS SENT TO A LAB FOR CONFIRMATION AND THE RESULT WAS ALSO NEGATIVE. THE TYPE OF DEVICE USED FOR THE SALIVA TEST IS UNKNOWN. NO ADVERSE CONSEQUENCES TO THE PATIENT BASED ON THE FALSE POSITIVE COC RESULTS. DONOR SPECIMEN WAS NOT AVAILABLE FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130056 MULTI DRUG 6 PANEL CUP DRUGS OF ABUSE LDJ ABON BIOPHARM (HANGZHOU) CO., LTD 4016600131 DOA4070682

    Patients

    Seq Age Sex Outcome Treatment
    1