BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG KIT

    MDR report key: 8824535 · Received July 24, 2019

    Report

    Report Number
    2027969-2019-00190
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO D4: UDI INFORMATION ADDED. CORRECTION TO D4: EXPIRATION DATE CORRECTED TO 31 OCTOBER 2020. INVESTIGATION CONCLUSION: AN INVESTIGATION WAS PERFORMED ON RETENTION DEVICES FROM THE REPORTED LOT NUMBER. RETENTION DEVICES WERE TESTED WITH CLINICAL NEGATIVE URINE SAMPLES. ALL DEVICES YIELDED EXPECTED NEGATIVE RESULTS AT 3 MINUTES. THE REPORTED ISSUE WAS NOT REPLICATED. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO SYSTEMIC ISSUE WAS IDENTIFIED. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. BATCH RECORD REVIEW FOUND NO RELEVANT NON-CONFORMANCES; THE LOT MET ALL FINAL RELEASE SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE LIMITATIONS SECTION OF THE PACKAGE INSERT: · A NUMBER OF CONDITIONS OTHER THAN PREGNANCY, INCLUDING TROPHOBLASTIC DISEASE AND CERTAIN NON-TROPHOBLASTIC NEOPLASMS INCLUDING TESTICULAR TUMORS, PROSTATE CANCER, BREAST CANCER, AND LUNG CANCER, CAUSE ELEVATED LEVELS OF HCG. THEREFORE, THE PRESENCE OF HCG IN URINE SPECIMEN SHOULD NOT BE USED TO DIAGNOSE PREGNANCY UNLESS THESE CONDITIONS HAVE BEEN RULED OUT. · AS WITH ANY ASSAY EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SPECIMEN. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HAMA. SUCH SPECIMENS MAY CAUSE FALSE POSITIVE OR FALSE NEGATIVE RESULTS. · THIS TEST PROVIDES A PRESUMPTIVE DIAGNOSIS FOR PREGNANCY. A CONFIRMED PREGNANCY DIAGNOSIS SHOULD ONLY BE MADE BY A PHYSICIAN AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED.

    Additional Manufacturer Narrative · 1

    RESULTS PENDING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED TO A FACILITY FOR BIRTH CONTROL. A URINE SAMPLE WAS TESTED (DIRTY CATCH FOR AN STD CHECK AS WELL) ON AN HCG URINE CASSETTE WITH A FALSE POSITIVE RESULT. THE ADMINISTERING OF BIRTH CONTROL WAS WITHHELD BASED ON THIS. ON THE SAME DAY A BETA HCG BLOOD TEST WAS PERFORMED WITH A RESULT OF <2MIU/ML. THE PATIENT WAS CONFIRMED TO NOT BE PREGNANT. NO NEGATIVE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616716 CONSULT DIAGNOSTICS HCG KIT HCG PREG TEST JHI ALERE SAN DIEGO FHC-A102 HCG8110038

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR