BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2252006 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09145
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 9, 2011
    Report Date
    September 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    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 K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011 THE METER WAS TESTED AND NO FAULTS WERE FOUND. ON (B)(6) 2011 THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN "ER2" ISSUE WHEN ATTEMPTING TO CHECK HER BLOOD GLUCOSE 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 BEGAN ON SEPTEMBER (B)(6) 2011, AT 8 AM. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH LANTUS AND NOVOLOG (SELF ADJUSTER) AND DUE TO THE ALLEGED ISSUE SHE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. AT 8:30 AM, WITHOUT AN EXACT GLUCOSE RESULT, SHE REPORTEDLY GUESSED AN APPROPRIATE AMOUNT OF INSULIN AND TREATED HERSELF (COULD NOT RECALL EXACT TYPE OR DOSE). SHE CLAIMED 1 HOUR LATER, AFTER THE ALLEGED ISSUE STARTED, SHE DEVELOPED A BLURRY VISION. IN RESPONSE TO HER SYMPTOM, SHE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THERE WAS NO INFORMATION OF MISUSE AND THE 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 A SERIOUS INJURY 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. 3179298

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening