BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 1438639 · Received August 13, 2009

    Report

    Report Number
    2030538-2009-00002
    Date Received
    August 13, 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

    ADD'L LOT # 091135.

    Description of Event or Problem · 1

    FALSE NEGATIVE PREGNANCY TEST RESULT [FALSE NEGATIVE PREGNANCY TEST]. CASE DESCRIPTION: SPONTANEOUS SERIOUS ADVERSE EVENT REPORT WAS RECEIVED ON (B)(6)-2009 FROM A HEALTH CARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A FEMALE PT (OTHERWISE UNIDENTIFIED) WITH AN ECTOPIC PREGNANCY. THE PT HAD A FALSE NEGATIVE TEST RESULT ON THE 101 OSOM HCG URINE TEST 50T ON AN UNSPECIFIED DATE. THE PT WAS REPORTED TO HAVE THE FOLLOWING SERUM QUANTS: 49 MIU, 53 MIU, 39 MIU AND 46 MIU. 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 (B)(6)-2009 FROM THE HEALTH CARE PROVIDER WHO REPORTED ON (B)(6)-2009, THE PT HAD A SERUM QUANT OF 49.2 MIU/ML, ON (B)(6)-2009, THE PT HAD A SERUM QUANT OF 53.2 MIU/ML, ON (B)(6)-2009, THE PT HAD A SERUM QUANT OF 38.5 MIU/ML, ON (B)(6)-2009, THE PT HAD A SERUM QUANT OF 46.1 MIU/ML AND ON (B)(6)-2009, THE PT HAD A SERUM QUANT OF 37.7 MIU/ML. AFTER THE FALSE NEGATIVE TEST RESULT WAS OBTAINED USING THE 101 OSOM HCG URINE TEST 50T (UNSPECIFIED DATE), THE PT WENT HOME AND USED A HOME PREGNANCY TEST AND HAD A POSITIVE RESULT. ON AN UNSPECIFIED DATE, THE PT HAD AN ULTRA-SOUND THAT DID NOT CONFIRM THE ECTOPIC PREGNANCY, BUT SHOWED THE PT HAD AN IUD IN PLACE. ON (B)(6)-2009, THE PT'S ECTOPIC PREGNANCY WAS DETERMINED. THE HCP REPORTED THE ECTOPIC PREGNANCY WAS DETERMINED BY THE SERUM QUANT RESULTS BECAUSE THE RESULTS NEVER GOT ABOVE 60 MIU/ML. THE HCP CONFIRMED THAT THE PT'S CARE WAS IMPACTED AS A RESULT OF THE FALSE NEGATIVE TEST RESULT BECAUSE THERE WAS A DELAY IN THE ADMINISTRATION OF METHOTREXATE. ON AN UNSPECIFIED DATE METHTREXATE WAS ADMINISTERED TO THE PT TO DISSOLVE THE PREGNANCY. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS UNK. ADDITIONAL INFO WAS RECEIVED ON (B)(6)-2009 FROM THE HEALTH CARE PROVIDER WHO REPORTED THAT THE PT WAS TREATED VIA THE HEALTHCARE FACILITIES NORMAL PROCEDURE FOR AN ECTOPIC PREGNANCY. THE PT WAS SENT TO THE HOSPITAL WHERE SHE RECEIVED AN INJECTION OF METHOTREXATE TO DISSOLVE THE PREGNANCY. THE HCP REPORTED THAT BECAUSE THE ECTOPIC PREGNANCY WAS DIAGNOSED SO EARLY, THE PT WAS NOT ADMITTED TO THE HOSPITAL. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other