BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID HCG URINE PREGNANCY CASSETTE

    MDR report key: 1791199 · Received August 2, 2010

    Report

    Report Number
    2027969-2010-01109
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER(S): 32192. EXPIRATION DATE(S): 09/2011. CONTROL: 20MIU/ML HCG URINE LOT: HCG100223-01, 100MIU/ML HCG URINE LOT: HCG090521-01, 237.6IU/ML HCG URINE LOT: HCG100420-01. CLINICAL NEGATIVE URINE. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME. (N=3). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 237.6IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). CORRECT NEGATIVE RESULTS WERE OBSERVED WHEN TESTED WITH 5 NEGATIVE URINE SAMPLES. (N=1 ON EACH SAMPLE). 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. INVESTIGATION ON RETURNED PRODUCT PENDING. UNABLE TO IDENTIFY THE ROOT CAUSE WITHOUT PATIENT SPECIMEN ANALYSIS IN-HOUSE. PRODUCT DEFICIENCY WAS NOT ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED THAT ONE OF THEIR CUSTOMERS HAD POTENTIAL FALSE NEGATIVE URINE HCG RESULTS ON THREE DIFFERENT PATIENTS. THE CUSTOMER EXPLAINED THAT THEY HAD THREE PATIENTS PRESENTED TO HER SITE AND ALL THREE GAVE NEGATIVE RESULTS AT THREE MINUTES. LATER, THE DEVICES HAD POSITIVE RESULTS (AFTER ALLOWABLE READ TIME). THE SAME URINE SAMPLES WERE TESTED ON DIFFERENT TEST DEVICES FROM THE SAME LOT NUMBER, BUT A DIFFERENT BOX OF DEVICES. ALL RESULTS WERE POSITIVE AT THREE MINUTES. ONE OF THE PATIENT¿S TEST RESULTS WAS CONFIRMED BY QUANTITATIVE TESTING (ACTUAL VALUE NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUPID HCG URINE PREGNANCY CASSETTE HCG PREGNANCY TEST JHI BIOSITE INCORPORATED FHC-102-ONC44 32192

    Patients

    Seq Age Sex Outcome Treatment
    1