BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER SURVUE HCG COMBO

    MDR report key: 1450211 · Received May 28, 2009

    Report

    Report Number
    2027969-2009-00366
    Event Type
    Malfunction
    Date Received
    May 28, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 27, 2009
    Manufacturer
    BIOSITE INC.
    Product Code
    JHI
    PMA / PMN Number
    993065
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: LOT NUMBER(S) : HCG8090146. EXPIRATION DATE(S) : 08/2010. CONTROL LOT: 25MIU/ML HCG URINE LOT: HCG090107-03, 100MIU/ML HCG URINE LOT: HCG081008-01, 279.2IU/ML HCG URINE LOT: HCG081229-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100MIU/ML AND 279.2IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED - THIS COMPLAINT IS NOT CONFIRMED. FOR INVESTIGATION AND RESULTS ON RETURNED DEVICES AND SAMPLES: RETURN 16 UNUSED DEVICES LOT: HCG8090146 EXP. 2010/08. RETURN 1 VIAL URINE AND 1 VIAL SERUM SPECIMEN. RETENTION DEVICE FROM LOT: HCG8090146 EXP. 2010/08. URINE STRIP (BAYER, MULTISTIX 10SG). RETURN SERUM SPECIMEN INVESTIGATION REPORT: THE RETURN 1 VIAL SERUM SPECIMEN FROM CUSTOMER WAS TESTED WITH RETURNED AND RETENTION DEVICES (N=1/EA), POSITIVE RESULTS WERE NOTED IN SERUM AT THE 5 - MINUTE READ TIME. THE SERUM SPECIMEN WAS QUANTIFIED AT A KNOWN REFERENCE LABORATORY (BAYER ACS: 180) AND SHOWED THE HCG LEVEL WAS 17 MIU/ML. RETURN URINE SPECIMEN INVESTIGATION REPORT: WHEN RUNNING THE1 VIAL RETURN URINE SPECIMEN FROM CUSTOMER WITH RETURN AND RETENTION DEVICE (N=3/EA), ALL THE SPECIMEN RESULTS WERE NEGATIVE IN URINE AT THE 3 - MINUTE READ TIME. NEGATIVE RESULTS WERE NOTED WHEN TESTING KNOWN NEGATIVE URINE WITH THE RETENTION AND RETURN DEVICE. THE URINE SPECIMEN WAS QUANTIFIED AT A KNOWN REFERENCE LABORATORY (BAYER ACS: 180) AND SHOWED THE HCG LEVEL WAS 24.7 MIU/ML. URINE STRIP (BAYER, MULTISTIX 10SG) TEST RESULT SHOWED NEGATIVE IN GLUCOSE, BILIRUBIN, KETONE AND POSITIVE WERE IN BLOOD (+++), PROTEIN (+++), NITRITE AND LEUKOCYEST (+++). UROBILINOGEN SHOWED NORMAL. SPECIFIC GRAVITY WAS 1.015 AND PH WAS 7.0. NOTHING ABNORMAL FOUND IN BATCH REVIEW AND THE PRODUCT NUMBER, PRODUCT DESCRIPTION AND LOT NUMBER WAS VERIFIED. NO CORRECTIVE ACTION REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    IN 2009 - FALSE NEGATIVE URINE HCG TEST RESULT. CALLER STATES THEY RECEIVED A POSITIVE SERUM RESULT AND A NEGATIVE URINE AT 3 MINUTES ON THE SURVUE SERUM/URINE HCG TEST KIT. BACK UP BETA HCG TEST WAS PERFORMED WITH A VALUE OF 16.7. PATIENT DISPOSITION - SURGICAL PROCEDURE PERFORMED, BUT NO INFORMATION ON TYPE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER SURVUE HCG COMBO HCG PREGNANCY TEST JHI BIOSITE INC. FHC-202-KFI30/50 HCG8090146

    Patients

    Seq Age Sex Outcome Treatment
    1 NI