BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2011018 · Received March 8, 2011

    Report

    Report Number
    2939301-2011-01978
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) ALLEGING HER ONETOUCH ULTRAMINI METER DOES NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR WHAT ACTION SHE TOOK AT THE TIME OF THE ALLEGED ISSUE. THE PATIENT CLAIMED SHE FELT SYMPTOMS OF DIZZINESS, SWEATING, HAD A HEADACHE, BLURRED VISION, VERY WEAK, TIRED AND NAUSEOUS. AT AN UNSPECIFIED DATE/ TIME, THE PATIENT VISITED HER PHYSICIAN'S OFFICE. THE PATIENT DID NOT SPECIFY TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE BATTERIES DID NOT NEED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3007260

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening