BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH RAPID TEST HCG COMBO 30T

    MDR report key: 9121641 · Received September 26, 2019

    Report

    Report Number
    2027969-2019-00495
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    JHI
    UDI-DI
    20885380020268
    PMA / PMN Number
    K062361
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE EVENT, THERE WAS NO INDICATION OF A REPORTABLE MALFUNCTION BASED ON INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4). ALERE (B)(4) UPDATED REPORTING DECISIONS AND CONDUCTED A RETROSPECTIVE REVIEW OF COMPLAINTS AGAINST THE UPDATED REPORTING DECISIONS. THIS MDR IS A RETROSPECTIVE FILING THAT WAS IDENTIFIED DURING THIS RETROSPECTIVE REVIEW ACTIVITY ASSOCIATED WITH AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED IN JANUARY 2019 AT ALERE (B)(4) (REFERENCE EIR (B)(4)). THE AWARENESS DATE IS BASED ON UPDATED REPORTING DECISIONS AND COMPLETION OF THE RETROSPECTIVE REVIEW ACTIVITY. THERE IS NO NEW OR INCREASED TREND BASED ON THIS RETROSPECTIVE REVIEW ACTIVITY. INVESTIGATION RESULTS: RETENTION AND RETURNED PRODUCTS WERE TESTED WITH CLINICAL NEGATIVE URINE, CLINICAL NEGATIVE SERUM, LOW HCG CONCENTRATION SERUM (2MIU/ML) AND LOW HCG CONCENTRATION URINE (4MIU/ML). ALL DEVICES YIELDED EXPECTED NEGATIVE RESULTS ON ALL SAMPLE TYPES AT THEIR RESPECTIVE READ TIMES. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. A ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. FROM THE COMPLAINT INFORMATION, PATIENT 1 SAMPLE WAS 8 MIU/ML OF HCG. THE FHC-A202B IS A SENSITIVE PRODUCT WITH CUTOFF OF 10MIU/ML HCG SERUM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON (B)(6) 2018 WAS HAVING A CAT SCAN DUE TO INVOLVEMENT IN AN AUTOMOBILE ACCIDENT. AT 8:59 AM THE PATIENT'S SERUM SAMPLE TESTED POSITIVE ON A RAPID HCG TEST. THE CAT SCAN WAS PERFORMED, "NOTHING" WAS FOUND; CUSTOMER COULD NOT VERIFY WHY THE NURSES PROCEEDED WITH THE CT SCAN AFTER OBTAINING A POSITIVE RESULT ON THE RAPID TEST. CUSTOMER DID NOT INDICATE ANY DELAY IN PERFORMING THE CT SCAN. THE SERUM SAMPLE WAS SENT OUT FOR BETA-HCG QUANT, RESULT: <2 MIU/ML. PATIENT HAD APPOINTMENTS SCHEDULED WITH OB-GYN DUE TO POSITIVE RAPID TEST RESULT WHICH WERE LATER CANCELLED AFTER CONFIRMATORY RESULT CAME BACK NEGATIVE. THERE WAS NO TREATMENT PERFORMED/WITHHELD BASED ON RAPID TEST RESULTS THIS FILE , 2027969-2019-00495, IS ONE OF TWO FILES. THE SECOND IS 2027969-2019-00494.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919518 CARDINAL HEALTH RAPID TEST HCG COMBO 30T HCG PREGNANCY TEST JHI ALERE SAN DIEGO FHC-A202 HCG7120056 20885380020268

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR