BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2233407 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08513
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE 510K # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. ON (B)(4) 2011 SMSS MAILED A LETTER REQUESTING THE PATIENT CONTACT MEDICAL SURVEILLANCE. ON (B)(4) 2011 AT NIGHTTIME, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS. TEN MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF FEELING HOT, SWEATY AND TIRED. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES WITH HUMULIN R INSULIN TAKEN ON A SLIDING SCALE AND LANTUS INSULIN 20 UNITS. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT AND THE METER POWERED ON SUCCESSFULLY WITH THE POWER BUTTON. THE ISSUE WAS NOT RESOLVED. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THESE WERE THE PATIENT'S SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, HER METER READINGS FROM EARLIER THAT DAY, THE MEALS AND MEDICATIONS TAKEN PRIOR TO THE ONSET OF SYMPTOMS AND THE PATIENT'S EXPECTED BLOOD GLUCOSE LEVELS. IT IS NOT KNOWN IF THE SYMPTOMS REPORTED WERE INDICATIVE OF SEVERE HYPERGLYCEMIA OR HYPOGLYCEMIA. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER POWER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3029192

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening