BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3251322 · Received July 29, 2013

    Report

    Report Number
    3008382007-2013-21313
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 21, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE LANCETS WERE MISSING FROM HER ONETOUCH ULTRA2 METER SYSTEM KIT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2013. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL MANAGEMENT ROUTINE. THE PATIENT ALLEGED SHE DEVELOPED SYMPTOMS DUE TO THE REPORTED ISSUE. ABOUT 30 MINUTES AFTER THE REPORTED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF SWEATY PALMS. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA EDUCATED THE PATIENT ON THE CORRECT SYSTEM KIT CONTENTS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352778 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3468994

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening