BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1981737 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01197
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING THE BATTERY INDICATOR. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS BETWEEN TWO TO FOUR TIMES A DAY AND MANAGES HER DIABETES WITH HUMALOG INSULIN (8 UNITS IN THE MORNING, 16 UNITS AT LUNCH AND DINNER, AND 32 UNITS IN THE EVENING). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN (B)(6) 2010 (DATE/TIME NOT KNOWN). AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CORRECTED AND CLARIFIED SHE CONTINUED WITH HER USUAL DOSE OF MEDICATION. ON AN UNKNOWN DATE/TIME IN (B)(6) 2010 (AFTER THE ALLEGED ISSUE OCCURRED) THE PATIENT CLAIMED SHE "PASSED OUT" AND HER DAUGHTER IMMEDIATELY CONTACTED THE EMERGENCY MEDICAL SERVICES (EMS). PRIOR TO PASSING OUT, THE PATIENT INDICATED SHE DID NOT TEST WITH ANOTHER DEVICE AND SHE DID NOT EXHIBIT ANY ADDITIONAL SYMPTOMS. THE PATIENT CLARIFIED SHE OBTAINED A BLOOD GLUCOSE RESULT OF "34MG/DL" WITH THE EMS'S METER AND CONFIRMED SHE WAS ADMINISTERED IV GLUCOSE BY THE HEALTH CARE PROFESSIONAL (HCP) AS TREATMENT. AFTER REGAINING CONSCIOUSNESS, THE PATIENT STATED SHE WAS ASKED (BY THE HCP) IF SHE WANTED TO BE TRANSPORTED TO THE HOSPITAL; HOWEVER, THE PATIENT DECLINED. THE PATIENT INDICATED SHE WAS FEELING BETTER AND DID NOT WANT TO GO TO THE HOSPITAL. BEFORE THE EMS DEPARTED, THE PATIENT STATED HER BLOOD GLUCOSE WAS NOT RETESTED (WITH THE EMS'S METER). DESPITE THE PATIENT'S REPORTED SYMPTOM, THE PATIENT INFORMED THE MSS SHE CONTINUED TO ADMINISTER HER USUAL DOSE OF INSULIN (WITHOUT TESTING ON ANOTHER DEVICE) UP UNTIL SHE CONTACTED LFS. DURING TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THE SUBJECT METER'S BATTERY WAS NOT REPLACED PER OWNER'S BOOKLET RECOMMENDATION AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052116

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R