BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP COCAINE 300

    MDR report key: 3663552 · Received November 15, 2013

    Report

    Report Number
    2027969-2013-01038
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 4, 2013
    Report Date
    October 22, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MVO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RETAIN PRODUCT PERFORMED AS EXPECTED WITH +50% CUTOFF CONTROL AND 3X CUTOFF CONTROL. MANUFACTURING DOCUMENT REVIEW DID NOT OBSERVE ANY FAILURE. THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED. THE PRODUCT PERFORMED AS EXPECTED. THE ISSUE WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE COCAINE RESULT WITH SURESTEP COCAINE 300 ON QUALITY CONTROLS. COMPLAINT SUMMARY: TEST DATE: (B)(6) 2013. MATRIX: URINE CHARGED WITH BENZOYLECGONINE 0, 5MG/L. LABORATORY: THE LAB YIELDED A NEGATIVE RESULT. TESTING: PERFORMED ON 45 CONTROLS; RESULTS AS FOLLOWS: FORTY (40) HAVE PROVIDED A POSITIVE RESULT. FOUR (4) HAVE PROVIDED A NEGATIVE RESULT. ONE (1) HAS PROVIDED A SUSPICIOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594878 SURESTEP COCAINE 300 DRUG OF ABUSE TEST MVO ALERE SAN DIEGO, INC. DCO-102 COC3050013

    Patients

    Seq Age Sex Outcome Treatment
    1