BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2213887 · Received August 17, 2011

    Report

    Report Number
    2939301-2011-07528
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 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

    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 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN ISSUE WITH THE BATTERY COVER ON HER SON'S ONE TOUCH ULTRASMART METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME OF THE DAY ON (B)(6) 2011. HE STATED THAT WHILE GOLFING, THE BATTERY COVER BROKE OFF, FELL OFF AND WAS LOST. HE REPORTED THAT HE TESTS HIS GLUCOSE 5-10X/DAY AND MANAGES HIS DIABETES WITH HUMALOG AND LANTUS (SLIDING SCALE). DUE TO THE ALLEGED ISSUE, AT 7:10 PM, AFTER THE PRODUCT ISSUE STARTED, THE PATIENT INCREASED HIS DOSE OF MEDICATION (UNABLE TO RECALL TYPE OR DOSE). HE STATED THAT HE WAS UNABLE TO TEST BECAUSE THE METER WOULD GO BLANK WHEN HE INSERTED THE STRIP, EVEN THOUGH THE BATTERIES WERE HELD IN PLACE AND HAD TO ESTIMATE THE AMOUNT OF INSULIN HE MAY HAVE NEEDED. HE CLAIMED THAT AT 7:30 PM OF THE SAME DAY, HE FELT NAUSEATED AND SHAKY. THE PATIENT COULD NOT RECALL HOW SOON AFTER HE SELF TREATED WITH FOOD AND DRINK IN RESPONSE TO HIS SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE ISSUE REMAINED UNRESOLVED. WHILE SPEAKING WITH THE PATIENT, HE STATED THAT HIS MAIN CONCERN WITH THE METER WAS THAT IT WOULD SHUT OFF PREMATURELY DURING USE AND IT WOULD NOT ALLOW HIM TO COMPLETE A GLUCOSE TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, ESTIMATED AND ADMINISTERED INSULIN SELF TREATMENT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3151191

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R