BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG DIPSTICK

    MDR report key: 1864578 · Received October 5, 2010

    Report

    Report Number
    2027969-2010-01654
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): HCG9120135. EXPIRATION DATE(S): 11/2011. CONTROL LOT: 25 MIU/ML HCG URINE CONTROL LOT: HCG100727-01, 100 MIU/ML HCG URINE CONTROL LOT: HCG100513-01, 228.6 IU/ML HCG URINE CONTROL LOT: HCG100420-02. SUMMARY OF RESULTS: THE RETENTION STRIPS MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 25 MIU/ML HCG URINE CONTROLS. (N=5). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 100 MIU/ML HCG URINE CONTROLS. (N=5). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 228.6 IU/ML HCG URINE CONTROLS. (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 FALSE NEGATIVE URINE HCG RESULTS USING CONSULT DIPSTICK VS. QUANTITATIVE SERUM RESULT. A FEMALE PT (B)(6) WAS TESTED AT OUR FACILITY AND A NEGATIVE URINE HCG RESULT WAS OBSERVED. THE PT'S SERUM QUANTITATIVE RESULT WAS 118 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULT DIAGNOSTICS HCG DIPSTICK HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101-OBC517 HCG9120135

    Patients

    Seq Age Sex Outcome Treatment
    1