BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON MEDI-LAB HCG COMBO

    MDR report key: 1491073 · Received August 4, 2009

    Report

    Report Number
    2027969-2009-00622
    Event Type
    Malfunction
    Date Received
    August 4, 2009
    Date of Event
    July 13, 2009
    Report Date
    August 3, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JHI
    PMA / PMN Number
    993065
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: LOT#(S): HCG8080032. EXP DATE(S): 07/2010. CONTROL LOT: 25MIU/ML HCG URINE, LOT: HCG090107-03. 100MIU/ML HCG URINE, LOT: HCG090521-01. 255.3IU/ML HCG URINE, LOT: HCG 090526-03. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100MIU/ML, 255.3IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. THE RETENTION DEVICES MEET QC SPECIFICATIONS. NO FALSE NEGATIVE RESULT WAS OBSERVED; THIS COMPLAINT IS NOT CONFIRMED. RETURN 8 UNUSED DEVICES LOT: HCG8080032 EXP 2010/0. RETURN 1 VIAL RETURN URINE SPECIMEN (0.5 ML). RETENTION DEVICE, LOT: HCG8080032 EXP 2010/07. WHEN RUNNING THE 1 VIAL RETURN URINE SPECIMEN FROM CUSTOMER WITH RETURN AND RETENTION DEVICE (N=1/EA), ALL THE SPECIMEN RESULTS WERE NEGATIVE IN URINE AT THE 3 - MINUTE READ TIME. THERE WAS INSUFFICIENT SAMPLE TO PERFORM HCG QUANT. RETURN URINE SPECIFIC GRAVITY WAS 1.022 AND PH WAS 5.0. FROM THE COMPLAINT INFO, IT IS STATED THAT HCG QUANT IN SERUM SAMPLE WAS 11.5, SO IT IS POSSIBLE TO GET A NEGATIVE RESULT IF THE URINE HCG LEVEL IS LOWER THAN THE CUTOFF (25MIU/ML). NOTHING ABNORMAL FOUND IN BATCH REVIEW AND THE PRODUCT #, PRODUCT DESCRIPTION AND LOT # WAS VERIFIED. NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO FALSE NEGATIVE URINE HCG RESULTS ON TWO DIFFERENT PTS. IN 2009, A FEMALE HAD FALSE NEGATIVE RESULTS AND A SERUM HCG QUANT RESULT OF 11.5. SPECIFIC GRAVITY ON THE URINE WAS 1.030.

    Description of Event or Problem · 2

    CUSTOMER REPORTED TWO FALSE NEGATIVE URINE HCG RESULTS ON TWO DIFFERENT PTS. APPROXIMATELY 6 WKS AGO, A DIFFERENT PT WAS NEGATIVE AT 3' WITH A FAINT LINE AT >3'. URINE WAS SENT TO HOSP LAB WHO GOT NEGATIVE AT 3' AS WELL; SERUM QUANT WAS 30; SPECIFIC GRAVITY WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON MEDI-LAB HCG COMBO HCG PREGNANCY TEST JHI BIOSITE INCORPORATED FHC-202-KMK25 HCG8080032

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR
    2 NI