BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-VUE SERUM/URINE HCG-STAT

    MDR report key: 1874379 · Received October 12, 2010

    Report

    Report Number
    2027969-2010-01709
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: HCG0010084, EXPIRATION DATE: 01/2012. CONTROL LOT: 20 MIU/ML HCG URINE LOT: HCG100223-01, 100 MIU/ML HCG URINE LOT: HCG100513-01, 228.6 IU/ML HCG URINE LOT: HCG100420-02. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20 MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME. (N=5). THE 100 MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=5). THE 228.6 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=5). 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 A FALSE NEGATIVE URINE HCG RESULT. PATIENT WAS TESTED ON (B)(6) 2010 AND URINE SAMPLE GAVE A NEGATIVE HCG RESULT. SAMPLE APPEARED TO BE SLIGHTLY HEMOLYZED. THE PATIENT CALLED CLIENT ON (B)(6) 2010 AND LET THEM KNOW THAT SERUM TEST WAS POSITIVE (WITH TWINS) - NO QUANTITATIVE VALUE OR ADDITIONAL INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE-VUE SERUM/URINE HCG-STAT HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBC513 HCG0010084

    Patients

    Seq Age Sex Outcome Treatment
    1