BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2192366 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06903
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 510(K) # IS K061118.

    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 ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER NOT TURNING ON BEGAN ON AN UNSPECIFIED TIME OF (B)(6) 2011. THE PATIENT PROCEEDED TO DISCARD THE METER AFTER IT STOPPED WORKING. SHE STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER), AND DUE TO THE ALLEGED PRODUCT ISSUE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. SHE CLAIMED THAT ON (B)(6) 2011, AT AN UNSPECIFIED TIME, SHE HAD RINGING IN THE EAR, FELT SHAKY, SWEATY AND HAD BLURRED VISION. IT IS UNKNOWN WHEN, BUT ON THE SAME DAY THE PATIENT REPORTEDLY SELF TREATED WITH 4U OF NOVOLOG AND ALSO TESTED WITH A FRIEND'S GLUCOSE METER WHERE SHE OBTAINED A GLUCOSE RESULT OF "33 MG/DL". IT IS UNCLEAR THE TIME DIFFERENCE BETWEEN THE TWO ACTIONS, OR IF ONE LED TO THE OTHER. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT STRIPS AND THERE WAS NO INFORMATION OF MISUSE OF THE METER. 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 HYPOGLYCEMIA, WHICH NEEDED INTERVENTION AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052323

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R