BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 3871502 · Received April 16, 2014

    Report

    Report Number
    2027969-2014-00341
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH HIGH LEVEL HCG POSITIVE URINE CONTROLS. ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MFG BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED W/O PT SPECIMEN IN-HOUSE ANALYSIS. BASED ON THE INFO, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE HCG RESULTS FOR ONE PT. RESULTS AS FOLLOWS: CUSTOMER REC'D A FALSE NEGATIVE HCG RESULT USING FIRST MORNING URINE FROM A PT WHO WAS (B)(6) PREGNANT. EXPIRATION DATE: 09/2015. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233161 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC202 HCG310029

    Patients

    Seq Age Sex Outcome Treatment
    1