BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 6411914 · Received March 16, 2017

    Report

    Report Number
    2027969-2017-00046
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: ADDITIONAL DEVICE INFORMATION WAS CORRECTED TO CHANGE THE MODEL NUMBER TO FHC-202. PREMARKET IDENTIFICATION WAS CORRECTED TO CHANGE THE PMA/510(K) NUMBER TO K993065.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S RESULTS WERE NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES OF THE REPORTED LOT. RETENTION DEVICES WERE TESTED WITH HCG-POSITIVE SERUM STANDARD AT THE QC CUTOFF (25 MIU/ML) AND ALL OF THE RESULTS WERE POSITIVE AT THE READ TIME. ALL RESULTS MET THE QC RELEASE SPECIFICATION. NO FALSE NEGATIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TWO UNCONFIRMED FALSE NEGATIVE HCG RESULT USING THE ICON 25 HCG COMBO CASSETTE USING SERUM. NO CONFIRMATORY TESTING WAS PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE PER DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192609 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202 HCG6040065

    Patients

    Seq Age Sex Outcome Treatment
    1