BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVUE PREGNANCY TEST

    MDR report key: 359805 · Received November 13, 2001

    Report

    Report Number
    MW1023330
    Event Type
    Malfunction
    Date Received
    November 13, 2001
    Date of Event
    January 1, 2001
    Report Date
    November 13, 2001
    Manufacturer
    WAMPOLE LABORATORIES, DIV OF CARTER WALLACE, INC.
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVES. THE CO DENIES THE PROBLEM. THEY TESTED 25 AND THEY WERE FINE. RPTR CONTACTED 2 FALSE POSITIVES LAST WEEK. THIS HAS BEEN OCCURRING FOR THE LAST SIX MONTHS. RPTR HAS THE SAMPLES. RPTR KNOWS THAT MANY OTHER SITES ARE HAVING THE SAME PROBLEMS. RPTR REPORTED THIS TO THEIR SUPV WHO DID NOTHING. THEN A PT CAME IN WITH PAIN/POSSIBLE ECTOPIC. SERUM HCG WAS NEGATIVE. WAMPOLE WAS CALLED AND SPOKE WITH SOMEONE WHO SAID THAT THE CO DID HAVE A PROBLEM WITH THE TEST BUT THE TESTS WERE PICKING UP A PROTEIN. A "GATE" WAS INSTITUTED AND SUPPOSEDLY THE FALSE POSITIVES STOPPED. RPTR SPOKE TO A MARKETING PERSON WHO DENIED THE PROBLEM THAT RPTR WAS JUST TOLD ABOUT. MARKETING APPEARED VERY UPSET THAT THIS INFO HAD BEEN GIVEN. CO THEN ASKED FOR LOT NUMBERS. RPTR HAD ONLY ONE. CO SAID THEY RAN 25 TESTS ON THE LOT AND THEY CAME OUT FINE. THEN CO REP ASKED RPTR WHAT THEY WOULD LIKE FOR THEM TO DO NOW. RPTR THOUGHT THIS WAS STRANGE. RPTR CALLED QUALITY CONTROL PERSON THAT GAVE THE INFO ABOUT THE "GATE" PROBLEM TO MAKE SURE THEIR JOB WAS NOT IN JEOPARDY. RPTR IS CONCERNED THAT CO IS COVERING UP THIS PROBLEM. TWO SAMPLE URINES HAVE BEEN GIVEN TO MFR. THEY WERE POSITIVE ON INITIAL TEST BUT MFR TESTED THEM AND THEY CAME OUT NEGATIVE. ADDITIONALLY, THERE ARE TWO INSERTS INCLUDED. ONE SAYS IT TAKES 3 MINS FOR TEST, THE OTHER SAYS FIVE AND THAT AFTER 5 MINS THERE COULD BE A FALSE POSITIVE. ALL THE TESTS RPTR CONDUCTED WERE POSITIVE WITHIN 90 SECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51274 PREVUE PREGNANCY TEST PREGNANCY TEST LCX WAMPOLE LABORATORIES, DIV OF CARTER WALLACE, INC. * 45267

    Patients

    Seq Age Sex Outcome Treatment
    1 *