BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLANNED PARENTHOOD URINE CASSETTE

    MDR report key: 1053243 · Received May 28, 2008

    Report

    Report Number
    3005689981-2008-00024
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    February 18, 2008
    Report Date
    May 28, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION DEVICE TESTING. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPEC. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL. THE 100MIU/ML AND 248.57IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. CONCLUSION: THE RETENTION DEVICES MEET QC SPEC. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A PA CAME IN FOR IUD INSERTION AND RAPID URINE HCG TEST WAS PERFORMED AND RESULT "NEGATIVE". PT CLAIMS LMP WAS 2008. OFFICE INSERTED IUD. PT RETURNED TO OFFICE, REASON UNK, THE FOLLOWING MONTH, (TIME UNK) AND RAPID URINE HCG TEST WAS "POSITIVE" THIS TIME. AN ULTRASOUND WAS PERFORMED AND SHOWED A 6 WEEK GESTATION ALONG WITH HER IUD. PT RETURNED ONE WEEK LATER, FOR PREGNANCY COUNSELING AND HAD ANOTHER ULTRASOUND WHICH SHOWED THE SAME AS THE FIRST. NO OTHER INFO WAS AVAILABLE ON THESE 2 PTS.

    Description of Event or Problem · 2

    IN 2008, (TIME NOT GIVEN), A PT CAME IN FOR AN IUD INSERTION SO A RAPID URINE HCG TEST WAS PERFORMED AND THE RESULT WAS "NEGATIVE". HOWEVER, THE IUD WAS DROPPED AND BROKE SO AN IDU WAS NOT INSERTED THAT DAY. THE PT CAME BACK TO THE OFFICE THE FOLLOWING MONTH, (TIME NOT GIVEN) FOR IUD INSERTION AND ANOTHER RAPID URINE HCG TEST WAS DONE AND IT SHOWED "NEGATIVE" RESULTS AGAIN SO AN IUD WAS INSERTED. PT 2 CLAIMS HER LMP WAS 2008. THE FOLLOWING MONTH, (TIME NOT GIVEN) THIS SAME PT CAME BACK BECAUSE SHE "FELT PREGNANT" AND HAD DONE A HOME PREGNANCY TEST WHICH WAS POSITIVE. A RAPID URINE HCG TEST WAS PERFORMED AND THIS TIME THE RESULT WAS "POSITIVE". AN ULTRASOUND WAS PERFORMED WHICH ALSO SHOWED A 6 WEEK INTRAUTERINE GESTATION. NO OTHER INFO WAS AVAILABLE ON THESE 2 PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLANNED PARENTHOOD URINE CASSETTE ONE STEP PREGNANCY TEST (URINE) LCX INNOVACON, INC. FHC-102-KPP40 HCG7060082

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR
    2 21 YR