BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCISE MONO TEST

    MDR report key: 5609 · Received May 18, 1993

    Report

    Report Number
    33642-1993-09001
    Event Type
    Injury
    Date Received
    May 18, 1993
    Date of Event
    January 28, 1993
    Report Date
    March 19, 1993
    Manufacturer
    HYBRITECH, INC.
    Product Code
    KTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 1/28/93, PATIENT WAS ADMINISTERED A TEST SCREENING FOR MONO TEST. THE PURCHASE DATAWAS 8/31/92, PER ATTACHED INVOICE. THE TEST WAS CONDUCTED WITHIN FOUR MONTHS OF THE PURCHASE DTE. PATIENT SHOWED A POSITIVE TEST RESULT AND WAS PRESCRIBED MEDICATION BY DOCTOR FOR TREATMENT OF MONO. PATIENT'S CONDITION WORSENED AND HE SUBSEQUENTLY SOUGHT MEDICAL TREATMENT FROM ANOTHER FACILITY WHERE HE INCURRED FURTHER MEDICAL BILLS FOR $621.50. TEST RESULT TAKEN AT THIS FACILITY REVEALED PATIENT DID NOT HAVE MONO, BUT DIAGNOSED AS HAVING ACUTE PHARYNGITIS. PATIENT RETURNED TO ORIGINAL FACILITY FOR AN EXPLANATION AND WAS RETESTED BY THE SAME LPN USING THE SAME CONSISE MONO TEST KIT AND SHOWED A NEGATIVE TEST RESULT. THE CONCISE TEST KIT HAD AN EXPIRATION DATE ON THE OUTSIDE BOX AS BEING 12/93, HOWEVER THE VIALS EXPIRATION DATES WERE 2/93INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCISE MONO TEST KTN HYBRITECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other