BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 2231030 · Received July 19, 2011

    Report

    Report Number
    2027969-2011-01583
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 19, 2011
    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

    CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG110105-01, 100MIU/ML HCG URINE CONTROL LOT: HCG110307-01, 260.1IU/ML HCG URINE CONTROL LOT: HCG110218-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MET QC SPECIFICATIONS. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READING TIME. (N=4). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=4). THE 260.1IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. (N=4). CONCLUSION: RETAIN TESTING OF THE PRODUCT MET SPECIFICATION. TESTING WITH HCG POSITIVE CONTROLS AT VARIOUS LEVELS ALL PRODUCED CLEAR POSITIVE RESULTS. NO FALSE NEGATIVE OR FAINT RESULTS WERE OBTAINED. RETURNED SAMPLES WERE TESTED AND YIELDED POSITIVE RESULTS. NEGATIVE RESULTS WERE NOT OBTAINED. REVIEW OF THE MANUFACTURING RECORDS DID NOT UNCOVER ANY ABNORMALITIES. NO PRODUCT DEFICIENCY WAS ESTABLISHED. ISSUE TO BE SUBJECT TO TRACK AND TREND. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE HCG RESULTS. RESULTS AS FOLLOWS: PATIENT'S URINE WAS TESTED AND GOT A NEGATIVE (-) RESULT USING THE ICON 25 HCG COMBO CASSETTE. TEST WAS REPEATED ON SAME SAMPLE FOUR TIMES AND GOT NEGATIVE (-) ON ALL RETESTS. PATIENT'S URINE WAS OBSERVED TO BE TURBID. PATIENT'S SERUM WAS QUANTITATED AND RESULT CAME BACK AT 176,000 MIU/ML. AFTER GIVING PATIENT HYDRATION VIA IV, PATIENT'S URINE WAS COLLECTED AND TESTED. PATIENT'S URINE, FOLLOWING IV HYDRATION WAS OBSERVED TO BE CLEARER. RESULT WAS A WEAK POSITIVE AND TEST WAS REPEATED FOUR TIMES AND ALL RETESTS WERE WEAK POSITIVE (+). ALL CONTROL LINES ON TESTS WERE GOOD. ALL TEST WERE DONE ON THE SAME DAY. PATIENT WAS INDICATED TO BE 7 TO 8 WEEKS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-202 HCG0110033

    Patients

    Seq Age Sex Outcome Treatment
    1