BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1790959 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06385
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON JULY 21, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRASMART METER DOES NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON JULY 29, 2010; HOWEVER, THE PATIENT WAS UNWILLING TO VERIFY OR PROVIDE ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 SOMETIME BETWEEN 6-7PM. THE PATIENT STATED HE DOES NOT MANAGE HIS DIABETES WITH ORAL MEDICATION OR INSULIN; HOWEVER, AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT STATED HE CONTINUED WITH HIS USUAL DIABETES ROUTINE. AFTER THE ALLEGED ISSUE OCCURRED (AT AN UNSPECIFIED TIME BETWEEN 6-7PM) THE PATIENT CLAIMED HE FELT SHAKY, COULD NOT HEAR CLEARLY, AND WAS CONFUSED. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS/GEL AT AN UNSPECIFIED TIME BETWEEN 6-7PM. THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER DID NOT TURN ON WITH POWER BUTTON OR TEST STRIP AND THE BATTERIES IN THE SUBJECT METER DID NOT NEED TO BE REPLACED, PER OWNER'S MANUAL RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WATER DAMAGE ON THE INSULIN PUMP, FOLLOWED BY AN ALARM. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2894186

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening