BEUDAMED
    FDA Adverse Event Summary report: N

    OSOM HCG URINE TEST (RAPID CLINICAL LABORATORY ASSAY) N/A

    MDR report key: 1429376 · Received August 5, 2009

    Report

    Report Number
    2030538-2009-00001
    Date Received
    August 5, 2009
    Date of Event
    April 22, 2009
    Report Date
    July 15, 2009
    Manufacturer
    GENZYME DIAGNOSTICS (SAN DIEGO)
    Product Code
    JHI
    PMA / PMN Number
    K953383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# 091135.

    Description of Event or Problem · 1

    DEPO-PROVERA ADMINISTERED TO PREGNANT PT DUE TO FALSE NEGATIVE URINE PREGNANCY TEST [DRUG EXPOSURE DURING PREGNANCY]. CASE DESCRIPTION: SPONTANEOUS SERIOUS ADVERSE EVENT REPORT WAS RECEIVED ON 15-JUL-2009 FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PREGNANT FEMALE PT (OTHERWISE UNIDENTIFIED). THE PT HAD A FALSE NEGATIVE TEST RESULT ON THE 101 OSOM HCG URINE TEST 50T ON AN UNSPECIFIED DATE. ON (B)(6) 2009, A SHOT OF DEPO-PROVERA WAS ADMINISTERED DUE TO THE RAPID RESULT. ON (B)(6) 2009, THE PT HAD 69199 MIU QUANT. THE SITE APPEARED TO BE PERFORMING THE 101 OSOM HCG URINE TEST 50 T CORRECTLY AND QC WAS PERFORMED FINE ON THE LOTS. ONE KIT WAS BEING RETURNED. THE LOT NUMBERS REPORTED WERE 081370 AND 081135. ADDITIONAL INFO WAS RECEIVED ON 23-JUL-2009 AND 24-JUL-2009 FROM THE HEALTHCARE PROVIDER WHO ADMINISTERED THE DEPO-PROVERA TO THE PT. THE HCP CONFIRMED THAT SHE ADMINISTERED DEPO-PROVERA TO THE PT BECAUSE OF THE FALSE NEGATIVE TEST RESULT. A 150 MG INJECTION OF DEPO-PROVERA MANUFACTURED BY (B)(4) WAS USED. THE PT WAS THREE WEEKS PREGNANT WHEN THE INJECTION WAS ADMINISTERED AND SHE DID NOT HAVE HER MENSTRUAL CYCLE AT THE TIME OF INJECTION. THE HCP REPORTED THAT THE PT WAS PRESENTED WITH OPTIONS AFTER RECEIVING DEPO-PROVERA WHILE PREGNANT, BUT THAT THE PT DECIDED SHE WAS GOING TO CONTINUE WITH THE PREGNANCY. THE PT WAS ADVISED TO RECEIVE A LEVEL TWO ULTRA SOUND, BUT THE HCP REPORTED THAT BECAUSE THE PT MADE HER OWN DECISION TO CONTINUE WITH THE PREGNANCY, THERE WAS NO OTHER COURSE OF ACTION. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. SEE (B)(4) FOR OTHER ADVERSE EVENTS FROM THIS REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSOM HCG URINE TEST (RAPID CLINICAL LABORATORY ASSAY) N/A UNKNOWN JHI GENZYME DIAGNOSTICS (SAN DIEGO) UNK 081370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other