BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-VUE SERUM/URINE HCG-STAT

    MDR report key: 2915388 · Received January 9, 2013

    Report

    Report Number
    2027969-2013-00018
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): HCG2060222. EXPIRATION DATE(S): 04/2014. CONTROL: 209.5 IU/ML HCG URINE CONTROL LOT: HCG120910-01; 230.2 IU/ML HCG URINE CONTROL LOT: HCG120917-01; 280.1 IU/ML HCG URINE CONTROL LOT: HCG120926-04. SUMMARY OF RESULTS: THE 209.5 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME WITH RETENTION DEVICES (N=10). THE 230.2 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME WITH RETENTION DEVICES (N=10). THE 280.1 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME WITH RETENTION DEVICES (N=9). CONCLUSION: CUSTOMER'S OBSERVATION WAS NOT REPRODUCED IN-HOUSE WITH RETENTION DEVICES. RETAIN DEVICES WERE TESTED WITH 3 DIFFERENT HIGH LEVELS OF HCG URINE CONTROLS. ALL RESULTS MET QC SPECIFICATIONS. NO FALSE NEGATIVES WERE OBSERVED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PT SPECIMEN ANALYSIS IN-HOUSE. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. TO DATE, ONE COMPLAINT OF THIS NATURE HAS BEEN REPORTED AGAINST THIS LOT. THIS ISSUE WILL BE TRACKED AND TRENDED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE RESULTS FOR ONE PT. RESULTS AS FOLLOWS: PT WENT TO THE ED TO CONFIRM PREGNANCY AND OBTAINED NEGATIVE RESULTS USING THE SURE-VUE SERUM/URINE HCG STAT TEST. BETA SERUM RESULTS WERE POSITIVE; SERUM VALUE WAS NOT PROVIDED. A FRESH URINE SPECIMEN WAS USED; VISUAL INSPECTION OF SPECIMEN SHOWED NOTHING UNUSUAL. NO LEAKAGE OR MIGRATION ISSUES WERE OBSERVED WITH THE DEVICE. EXTERNAL CONTROLS WERE "OK." PT IS (B)(6). SAMPLE WAS NOT AVAILABLE FOR IN HOUSE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12035 SURE-VUE SERUM/URINE HCG-STAT HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-A202-OBC513 HCG2060222

    Patients

    Seq Age Sex Outcome Treatment
    1