BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2183468 · Received July 29, 2011

    Report

    Report Number
    2939301-2011-06503
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS HAVING AN ISSUE WITH "OTHER MESSAGE". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT AT AN UNSPECIFIED DATE AND TIME ON THE LAST WEEK OF (B)(6) 2011, SHE ALLEGEDLY OBTAINED A DISPLAY OF "HI" ON THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND TOOK HER USUAL DOSE OF DIABETES MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. IN THE MORNING OF (B)(6) 2011, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "DIABETES SHOCK" AND IN RESPONSE TO THE SYMPTOMS, IMMEDIATELY CALLED EMS, WHO TREATED THE PATIENT WITH "IV GLUCOSE". THE CCA WAS ALSO INFORMED BY THE PATIENT THAT SHE WAS TESTED ON THE EMS METER (UNKNOWN DEVICE) BUT THE RESULT OBTAINED FROM THAT DEVICE IS UNKNOWN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING PROCEDURE AS RECOMMENDED PER THE OWNER'S BOOKLET AND THAT THERE WAS NO MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND THAT SHE RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED METER ISSUE. IN ADDITION, THE REPORTED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3004212

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening