BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3961924 · Received July 28, 2014

    Report

    Report Number
    2939301-2014-18815
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 22, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2014 AT 7:30 AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NOVOLIN R, SLIDING SCALE AND HUMULIN 70/30); HOWEVER, IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK FOLLOWING THE ALLEGED POWER ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, SIX HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF PAIN IN THE LEG, DIZZINESS, AND DRY THROAT; AND ON (B)(6), THE PATIENT ADMINISTERED AN UNSPECIFIED INCREASED DOSE OF INSULIN AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME; THERE WAS NO MISUSE OF THE LFS PRODUCTS; THE PATIENT WAS USING THE CORRECT TEST STRIPS AT THE TIME THE ALLEGED ISSUE OCCURRED; THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE (PER OWNER¿S BOOKLET); AND THE SUBJECT METER TURNED ON MANUALLY WITH THE POWER BUTTON. HOWEVER, THE ALLEGED ISSUE REMAINS UNRESOLVED SINCE THE PATIENT DID NOT HAVE ANY TEST STRIPS AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438122 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3613158

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R