BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST

    MDR report key: 2060660 · Received April 8, 2011

    Report

    Report Number
    2027969-2011-00756
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT: 25MIU/ML, HCG URINE CONTROL LOT: HCG110105-01, 100MIU/ML, HCG URINE CONTROL LOT: HCG100513-01, 278.9IU/ML, HCG URINE CONTROL LOT: HCG110124-01. SUMMARY OF RESULTS: THE RETENTION STIRPS MEET QC SPEC. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL. (N=5). CORRECT POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 100MIU/ML HCG URINE CONTROL. (N=5). CLEARLY POSITIVE RESULTS WERE OBSERVED AT 3 MINUTE READ TIME WHEN TESTED WITH 278.9IU/ML HCG URINE CONTROL. (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 SPECS. VERIFIED THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. CUSTOMER'S OBSERVATION COULD NOT BE REPRODUCED IN-HOUSE WITH CONTROL SAMPLES. NO FALSE NEGATIVE WAS OBSERVED. THIS ISSUE WILL BE TRACKED AND TRENDED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS USING (B)(6) ONE STEP+ HCG URINE STRIP TEST. ONE PT WAS REPORTED TO HAVE CONFLICTING RESULTS WHEN TESTING FOR URINE HCG. THE END USER PROVIDED THE FOLLOWING INFO: THE FIRST TEST WAS NEGATIVE. A SECOND TEST WAS RUN A FEW MINUTES LATER AND THE RESULT WAS ALSO NEGATIVE. NO SERUM TEST WAS PERFORMED. THE FINAL DIAGNOSIS WAS 'PREGNANT' BUT METHOD OF DETERMINING THIS WAS NOT PROVIDED. THE PT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101-KHS25 HCG9120190

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR