BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2232953 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08510
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    August 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING A POWER ISSUE WITH HER ONE TOUCH ULTRA METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(4) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED DAY ON THE FIRST WEEK OF (B)(6) 2011. SHE STATED THAT SHE MANAGES HER DIABETES WITH METFORMIN AND GLYBURIDE AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES TREATMENT. THE PATIENT WAS UNABLE TO RECALL WHEN THE SYMPTOMS STARTED, BUT CLAIMED WAS APPROXIMATELY A WEEK LATER, WHEN SHE FELT 'WEAK, DROWSY AND DIDN'T WANT TO DO ANYTHING' AND HAD 'BLURRY VISION'. SHE REPORTED MAKING AN APPOINTMENT WITH HER DOCTOR APPROXIMATELY 2 WEEKS LATER, AFTER THE ALLEGED ISSUE STARTED TO GET HELP WITH HER OVERALL CONDITION. THE PATIENT STATED ON AN UNSPECIFIED DAY THE DOCTOR TESTED HER GLUCOSE WITH HIS METER AND OBTAINED A RESULT OF '480 MG/DL'. SHE REPORTED THAT HE IMMEDIATELY TREATED HER WITH AN INSULIN INJECTION (UNKNOWN DOSE AND TYPE) AND KEPT HER IN THE OFFICE UNTIL SHE FELT BETTER. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE BATTERY NEEDED TO BE REPLACED BUT THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY. 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 HYPERGLYCEMIA AND THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3104098

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R