BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHTEK UBT COLLECTION KIT

    MDR report key: 2894830 · Received January 17, 2007

    Report

    Report Number
    1060925-2007-00002
    Event Type
    Other
    Date Received
    January 17, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 16, 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
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING BACKGROUND INFO. MERETEK CONTRACTS OUT THE MANUFACTURE OF THE BREATHTEK UBT COLLECTION KIT, WHICH OCCURS IN THREE SEPARATE PHASES: PHASE 1 - 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 HERITAGE LABS INTERNATIONAL, LLC. THE FINISHED BREATHTEK UBT COLLECTION KITS ARE DISTRIBUTED BY (B)(4) TO MERETEK DIAGNOSTICS, INC. CLIENTS.

    Description of Event or Problem · 1

    A FEW MINUTES AFTER THE PT DRANK THE PRANACTIN CITRIC DRUG SOLUTION AS PART OF THE BREATHTEK UBT H. PYLORI TEST, SHE REPORTED DISCOMFORT AND NUMBNESS IN LIMBS, SHE WAS FLUSHED AND WAS HAVING HEART PALPITATIONS, AND WAS FEELING ANXIOUS, THE BACK OF HER FELT HOT AND COLD OVERALL.

    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 22 YR Hospitalization| O