BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH RAPID TEST HCG CASS. 30T

    MDR report key: 6143528 · Received December 2, 2016

    Report

    Report Number
    2027969-2016-00700
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 4, 2016
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION AND RETURN PRODUCTS. RETENTION PRODUCTS WERE TESTED WITH 25MIU/ML HCG AND THREE HIGH LEVEL HCG URINE CONTROLS. RETENTION PRODUCTS SHOWED HCG POSITIVE RESULTS AT READ TIME AND MET QC SPECIFICATIONS. NO FALSE NEGATIVE RESULTS WERE OBTAINED. RETURNED PRODUCTS WERE TESTED WITH RETURNED URINE SAMPLES AND BOTH SAMPLES SHOWED NEGATIVE RESULTS. RETURNED PRODUCT WAS ALSO TESTED WITH RETURNED SERUM SAMPLE AND A POSITIVE RESULT WAS OBTAINED. CUSTOMER'S OBSERVATION WAS VERIFIED. THE RETURNED SAMPLES WERE SENT TO A REFERENCE LAB AND IT WAS OBSERVED THAT THE HCG LEVELS IN THE RETURNED URINE SAMPLES WERE LESS THAN THE DETECTABLE LEVELS OF THE DEVICE. HOWEVER, A NEGATIVE RESULT WITH THE URINE SAMPLE IS THE EXPECTED OUTCOME. THEREFORE, NO PROBLEM WAS DETECTED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED THE FOLLOWING TIMELINE OF EVENTS: ON (B)(6) 2016, THE PATIENT WENT TO THE EMERGENCY ROOM FOR PELVIC PAIN FROM FALL. AT 12:45PM: CARDINAL HEALTH HCG TEST PRODUCED FALSE NEGATIVE RESULT. SAMPLE WAS COLORLESS/CLEAR AND SHOWED A SPECIFIC GRAVITY OF 1.002. AT 3:13PM: CARDINAL HEALTH HCG TEST ON NEW SAMPLE PRODUCED FALSE NEGATIVE RESULT. NO NOTATION OF SAMPLE COLOR OR CLARITY. A THIRD FALSE NEGATIVE HCG WAS OBTAINED ON CARDINAL HEALTH HCG TEST USING SAME SAMPLE AS ONE OF PREVIOUS TESTS. A SERUM SAMPLE WAS RUN ON THE ROCHE COBAS WITH AN HCG RESULT OF 9946.0 MIU/ML. AN X-RAY WAS CONDUCTED ON THE PATIENT IN THE EMERGENCY ROOM DURING VISIT. PATIENT DETERMINED TO BE 31 WEEKS PREGNANT. LAST MENSTRUAL PERIOD UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794008 CARDINAL HEALTH RAPID TEST HCG CASS. 30T HCG PREGNANCY TEST JHI FHC-102 HCG6060227

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other