BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2220398 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07855
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 8, 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. 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 HIS 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 APPROXIMATELY (B)(6) 2011, AT APPROXIMATELY 5 PM. HE CLAIMED THAT A FEW HOURS AFTER THE ALLEGED PRODUCT ISSUE STARTED, HE DEVELOPED SYMPTOMS OF CONFUSION, DRY MOUTH, FRUSTRATION, ANGER, LETHARGY, DEHYDRATION & CONSTANT URINATION. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER) AND DUE TO THE ALLEGED ISSUE, ON (B)(6) 2011 AT 11 AM HE HAD LESS FOOD AND DRINK. REPORTEDLY AT THE EXACT SAME TIME HE WAS IN THE URGENT CARE CLINIC, WHERE THERE WAS NO TREATMENT PROVIDED. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE ISSUE REMAINED UNRESOLVED. 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 AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA 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. 2967070

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening