BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN OEN STEP+ HCG URINE STRIP TEST

    MDR report key: 3032681 · Received March 29, 2013

    Report

    Report Number
    2027969-2013-00264
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED RECEIVING FALSE NEGATIVE RESULTS APPROX 10 TIMES IN ONE MONTH. THE CUSTOMER STATED THE STRIPS WERE NOT SUBMERSED PAST THE MAX LINE. IT IS UNK IF A TIMER WAS USED, BUT REPORTED READ TIME WAS 3 MINUTES. EXTERNAL CONTROLS WERE NOT RAN. INTERNAL CONTROL LINE WAS NOT EVIDENT AND BACKGROUND WAS CLEAR. PT SPECIFIC INFO WAS NOT AVAILABLE FROM THE CUSTOMER. THE CUSTOMER REPORTED THAT SHE TESTED HERSELF AND ONLY ONE LINE APPEARED UNDER "T". THE CONTROL LINE DID NOT APPEAR. PER PRODUCT INSERT, THIS RESULT IS CONSIDERED INVALID DUE TO CONTROL LINE NOT APPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129792 HENRY SCHEIN OEN STEP+ HCG URINE STRIP TEST HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-101-KHS25 HCG2070158

    Patients

    Seq Age Sex Outcome Treatment
    1