BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULT HCG DIPSTICK TEST 5000 25T

    MDR report key: 9114310 · Received September 24, 2019

    Report

    Report Number
    2027969-2019-00307
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    January 10, 2017
    Report Date
    September 24, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SAN DIEGO. ALERE SAN DIEGO 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 SAN DIEGO (REFERENCE (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: THE CUSTOMER'S RESULTS WERE NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES OF THE REPORTED LOT. RETENTION DEVICES TESTED WITH CLINICAL HCG-NEGATIVE URINE PRODUCED NEGATIVE RESULTS AT THE READ TIME. ALL RESULTS MET THE QC SPECIFICATION. FALSE POSITIVE RESULTS WERE NOT OBSERVED DURING IN-HOUSE TESTING. A REVIEW OF MANUFACTURING BATCH RECORDS DID NOT UNCOVER ANY ABNORMALITIES. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS GOING TO HAVE AN X-RAY BUT HAD A FALSE POSITIVE X 3 WITH 1 URINE SAMPLE ON THE HCG TEST. THEREFORE, THE X-RAY WAS NOT PERFORMED. SERUM BETA QUANT TESTED AT <0.5 MIU/ML (NORMAL RANGE=<5.0 MIU/ML), INSTRUMENT NOT KNOWN, TEST WAS SENT OUT TO REFERENCE LAB. TROUBLESHOOTING OCCURRED WITH A DISCUSSION REASONS FOR FALSE POSITIVE SUCH AS HAMA, AUTOANTIBODIES, DISEASE STATES, DEVIATION FROM DESIGNATED READ TIME. NO DEVIATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901951 CONSULT HCG DIPSTICK TEST 5000 25T HCG PREGNANCY TEST JHI ALERE SAN DIEGO FHC-101 HCG6070035

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other