BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDS HCG-URINE

    MDR report key: 2646 · Received January 28, 1993

    Report

    Report Number
    2023733-1992-09001
    Event Type
    Malfunction
    Date Received
    January 28, 1993
    Date of Event
    December 4, 1992
    Report Date
    December 23, 1992
    Manufacturer
    PACIFIC BIOTECH, INC.
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOUR CUSTOMER COMPLAINTS REPORTED THAT MONO CARD REACTION UNITS WERE FOUND IN CARDS HCG-URINE TEST KITS. THE MONO CARD REACTION UNITS WERE LABELED WITH THE WORD MONO ON THE OUTER REACTION UNIT POUCH. THE USE OF THE MONO CARD REACTION UNIT USING URINE SAMPLES WOULD RESULT IN A NEGATIVE RESULT. IF THE MONO CARD WAS USED ON A POSITIVE HCG PATIENT SAMPLE IT COULD RESULT IN A FALSE NEGATIVE RESULT. PACIFIC BIOTECH, INC. HAS INITIATED CUSTOMER PRODUCT RECALLS FOR TWO CARD HCG-URINE KIT LOTSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDS HCG-URINE N/A DHA PACIFIC BIOTECH, INC. N/A 570277.1; 580210.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other