BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE HCG COMBO CASSETTE (20/10)

    MDR report key: 3843558 · Received March 25, 2014

    Report

    Report Number
    2027969-2014-00269
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH SERUM/URINE CUTOFF LEVEL HCG CONTROL AND 3 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. CUSTOMER DID NOT FOLLOW PACKAGE INSERT PROCEDURES AND INCORRECT SAMPLE WAS APPLIED. THE ROOT CAUSE WAS CONFIRMED AS A CUSTOMER IMPROPER TECHNIQUE. BASED ON THE INFO AVAILABLE, 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 REPORTED POTENTIAL FALSE NEGATIVE RESULTS WITH ALERE HCG COMBO CASSETTE (20/10) WHEN TESTING FIVE DIFFERENT PTS USING WHOLE BLOOD FINGERSTICK SAMPLES. ONE PT WAS 30 YEARS OLD; THE OTHER FOUR PTS WERE OVER THIRTY AND ONLY ONE HAD LAB RESULTS PROVIDED. CUSTOMER DID NOT ALLOW CASSETTES TO COME TO ROOM TEMPERATURE BEFORE TESTING. CUSTOMER WAS NOT USING A TIMER WHILE TESTING (READING RESULTS UP TO 10 MINUTES AFTER APPLYING SAMPLE). CUSTOMER IS TESTING WITH WHOLE BLOOD FINGERSTICK SAMPLE. FOUR OTHER PTS WERE ALL ABOVE THIRTY AND NO OTHER INFO WAS AVAILABLE. TECHNICAL SERVICE REP ADVISED CUSTOMER TO USE EITHER SERUM OR URINE SAMPLE; ALLOW CASSETTES TO COME TO ROOM TEMPERATURE PER THE PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173993 ALERE HCG COMBO CASSETTE (20/10) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202 HCG3060263

    Patients

    Seq Age Sex Outcome Treatment
    1