BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHTEK UBT COLLECTION KIT

    MDR report key: 899831 · Received April 23, 2007

    Report

    Report Number
    1060925-2007-00001
    Event Type
    Other
    Date Received
    April 23, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 23, 2007
    Manufacturer
    MERETEK DIAGNOSTICS, INC.
    Product Code
    MSQ
    PMA / PMN Number
    K000316
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    MERETEK CONTRACTS OUT THE MANUFACTURE OF THE BREATHTEK UBT COLLECTION KIT, WHICH OCCURS IN THREE SEPARATE PHASES: PHASE I - MANUFACTURE OF THE BULK GRANULATED PRANACTIN-CITRIC DRUG COMPONENT. THIS PART OF THE MANUFACTURE IS PERFORMED BY VPS CORPORATION. PHASE II - PACKAGING THE BULK PRANACTIN-CITRIC DRUG COMPONENT INTO POUCHES. THIS PART OF THE MANUFACTURE IS PERFORMED BY CARDINAL HEALTH. PHASE III - ASSEMBLY OF THE KIT COMPONENTS INTO THE BREATHTEK UBT COLLECTION KIT. THIS ASSEMBLY IS PERFORMED BY DISTRIBUTOR. THE FINISHED BREATHTEK UBT COLLECTION KITS ARE DISTRIBUTED TO MERETEK DIAGNOSTICS, INC. CLIENTS.

    Description of Event or Problem · 1

    PATIENT VOMITED AFTER INGESTING THE PRANACTIN -CITRIC SOLUTION. PRANACTIN-CITRIC IS THE DRUG COMPONENT OF THE BREATHTEK UREA BREATH TEST FOR H. PYLORI INFECTION. TEST WAS ADMINISTERED FOR POST TREATMENT MONITORING OF H. PYLORI INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHTEK UBT COLLECTION KIT BREATHTEK UBT COLLECTION KIT MSQ MERETEK DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other PREMARIN| ZOCOR