BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1904276 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10205
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER DOES NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT/REPORTER BY PHONE FOR FOLLOW-UP QUESTIONS. 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) 2010 AT 8AM. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH A SET DOSE OF LANTUS INSULIN (20 UNITS BEFORE BED) AND NOVOLOG INSULIN (3 UNITS AFTER EACH MEAL) AND IS ALSO ON A SLIDING SCALE (INSULIN TYPE UNCLEAR). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER ACTIVITY LEVEL, REGIMEN, OR DIET AFTER THE ALLEGED BEGAN AND IT IS ALSO NOT KNOWN IF THE PATIENT CONTINUED TO MONITOR HER BLOOD GLUCOSE WITH ANOTHER DEVICE. NINETEEN HOURS LATER, THE PATIENT REPORTEDLY WENT INTO SEIZURE AND COMA. THE PATIENT ALLEGEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "28 MG/DL" WITH THE EMERGENCY MEDICAL SERVICE'S METER (AT APPROXIMATELY 3AM ON (B)(6) 2010) AND WAS ADMINISTERED IV FLUIDS AND A GLUCOSE GEL BY THE HEALTH CARE PROFESSIONAL (HCP) SOON AFTER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER'S BOOKLET RECOMMENDATION. THE PATIENT DENIED TRAUMA TO THE SUBJECT METER. THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY WAS TREATED FOR HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R