BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1871705 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09103
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K062195.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

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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 (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WOULD NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE PATIENT ON OCTOBER 15, 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE PATIENT INFORMED THIS MSS THAT SHE TESTS 2X/DAY AND MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN). DESPITE NOT BEING ABLE TO TEST HER BLOOD GLUCOSE, THE PATIENT CLAIMED SHE TOOK HER USUAL DOSE OF ORAL MEDICATION. APPROXIMATELY 5 MINUTES AFTER THE ALLEGED ISSUE BEGAN; THE PATIENT CLAIMED SHE BEGAN TO FEEL SHAKY, SWEATY AND NERVOUS. THE PATIENT STATED THAT SHE DEVELOPS THESE SYMPTOMS WHEN HER BLOOD GLUCOSE IS LOW AND WHEN SHE IS HAVING AN "ANXIETY ATTACK." IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED THAT SHE TOOK SOME GLUCOSE TABLETS AND THEN ATE HER BREAKFAST. THE PATIENT CONFIRMED FEELING BETTER AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER'S BOOKLET RECOMMENDATION. THE POWER 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 DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) COMPLAINING OF A SHOCKING SENSATION IN THE "MIDDLE OF THE BRAIN." THE PATIENT HAD BEEN TOLD TO TURN THE DEVICE OFF, WHICH HE HAD DONE PRIOR TO THE ER VISIT. THIS WAS CORROBORATED BY A RETURN OF SYMPTOMS, BUT THE HEALTH CARE PROFESSIONAL COULD NOT CONFIRM VISUALLY BECAUSE THERE WAS NO PROGRAMMER AVAILABLE AT THE TIME. THE PATIENT WAS ADMITTED TO THE HOSP. IT WAS INDICATED THAT ABOUT ONE MONTH AGO, THE PT BANGED INTO A CLOTHES LINE POLE AND HIT THE AREA WHERE THE LEAD WAS IMPLANTED. SINCE THEN, THE PT STARTED EXPERIENCING AN INTERMITTENT SHOCKING SENSATION IN THE BRAIN DURING NIGHT WHILE STIMULATION WAS TURNED OFF (THE PATIENT TURNED OFF STIMULATION PRIOR TO GOING TO BED AND TURNED IT BACK ON IN THE MORNING). IN THE PAST FOUR DAYS, THE SHOCKING SENSATION WAS OCCURRING ALSO DURING THE DAY. IMPEDANCE LEVELS WERE NORMAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3009671

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R