BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 2123345 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01301
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG110105-01, 100MIU/ML HCG URINE CONTROL LOT: HCG110307-01, 278.9IU/ML HCG URINE CONTROL LOT: HCG110124-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MIN READ TIME (N=4). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MIN READ TIME (N=3). THE 278.9IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MIN READ TIME (N=3). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECIFICATIONS. VERIFIED THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED THREE INSTANCES OF POTENTIAL FALSE NEGATIVE URINE HCG RESULTS VS. SERUM QUANTITATIVE RESULTS. IN THE LAST WEEK OR SO, THE CUSTOMER HAD THREE INSTANCES WHERE THEY WERE GETTING NEGATIVE TEST RESULTS ON PT URINE SAMPLES WHILE THE SERUM QUANTITATIVE RESULTS WERE FROM 49 TO 200,000MIU/ML. THE THIRD INSTANCE OCCURRED TODAY ((B)(6) 2011) WHERE THE URINE HCG RESULT WAS NEGATIVE AND THE SERUM QUANTITATIVE VALUE WAS 72,000MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202 HCG0120539

    Patients

    Seq Age Sex Outcome Treatment
    1