BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT LABS

    MDR report key: 412294 · Received August 8, 2002

    Report

    Report Number
    MW1025923
    Event Type
    Other
    Date Received
    August 8, 2002
    Date of Event
    June 26, 2001
    Report Date
    August 8, 2002
    Manufacturer
    *
    Product Code
    JHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE RPTR'S GENERAL PRACTITIONER RAN A SERUM HCG TEST TO RULE OUT PREGNANCY AS THE SOURCE OF RPTR NOT FEELING WELL. THE TEST CAME BACK POSITIVE THIS TIME AND THE NEXT 16 TIMES RPTR TOOK IT, RANGING FROM A READING OF 29-281, OVER THE COURSE OF SEVEN WEEKS. INITIALLY, RPTR WAS TREATED FOR MISCARRIAGE, THEN WHEN THE POSITIVE HCG LEVELS PERSISTED RPTR'S OB/GYN TREATED THEM FOR AN ECTOPIC PREGNANCY. RPTR RECEIVED TWO DOSES OF METHOTREXATE AND FINALLY AN EMERGENCY LAPAROSCOPY AND D&C. THEY FOUND NO EVIDENCE OF A PREGNANCY. WHEN RPTR ASKED WHAT ELSE COULD PRODUCE A POSITIVE HCG READING, THE DRS SAID THAT THE ONLY OTHER THING WOULD BE GESTATIONAL TROPHOBLASTIC DISEASE. RPTR BEGAN CANCER TESTS: LUNG X-RAY, CEA AND CA125, AS ORDERED BY THEIR OB/GYN GROUP AND THROUGH ANOTHER SPECIALIST RPTR CONSULTED WITH. THEN RPTR CALLED A GYNECOLOGICAL ONCOLOGIST AND HE, ALONG WITH ANOTHER DR, CORRECTLY DIAGNOSED THEM AS BEING FINE. DR GAVE THEM A URINGE PREGNANCY TEST - SINCE BLOOD TESTS ARE CONSIDERED THE 'GOLD STANDARD', THE OTHER DRS HADN'T GIVEN THEM ONE. RPTR HAS HETEROPHILIC ANTIBODIES, WHICH CAUSE A FALSE POSITIVE SERUM HCG READING ON MOST COMMERCIAL PREGNANCY TESTS (BUT DO NOT AFFECT URINE TESTS). ACCORDING TO THE DR AND OTHER RESEARCH WHICH RPTR HAS DONE, IMMUNOASSAYS CAN BE PROPERLY PROTECTED AGAINST FALSE POSITIVES, BUT THE STANDARDS DO NOT EXIST YET. COMPLICATING RPTR'S CASE IS THE FACT THAT THE LAB WAS CONVERTING FROM THE ABBOTT AXSYM TO THE CENTOR HCG TEST, BUT ONE FACILITY HAD CONVERTED FASTER THAN THE OTHER AND RPTR'S BLOOD WENT BACK AND FORTH BETWEEN THE FACILITIES. THE TWO TESTS HAD A SIGNIFICANTLY DIFFERENT 'AVERAGE' READING, SO RPTR'S RESULTS WENT UP AND DOWN A GREAT DEAL, CAUSING THE DRS TO THINK THAT RPTR WAS RESPONDING TO WHATEVER TREATMENT THEY HAD JUST GIVEN THEM. ABBOTT HAD THIS SAME PROBLEM WITH TESTS FOR TSH AND TROPONIN, BUT WERE COMPELLED TO CHANGE THEM. LAWYERS WORKING ON RPTR'S CASE AND OTHERS LIKE IT WERE BARRED FROM DISCOVERY, SO THEY DO NOT KNOW HOW ABBOTT WAS FORCED TO FIX THOSE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABS AXSYM-SERUM HCG TEST JHI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other