BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2063565 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03238
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/23/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011. A CAPACITOR FAILURE WAS OBSERVED WITH THE RETURNED METER, WHICH CAN CONTRIBUTE TO THE ALLEGED POWER ISSUE. 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 HIS ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY 5 MONTHS AGO PRIOR TO CONTACTING LFS. THE PATIENT STATED HE WAS NOT TAKING ANY DIABETES MEDICATIONS, BUT WAS CONSUMING MORE FOOD AND/OR DRINK ON (B)(6) 2011 DUE TO THE ALLEGED ISSUE. ON (B)(6) 2011, THE PATIENT REPORTED SYMPTOMS OF "COLD SWEAT" AND DIZZINESS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT INDICATED HE WENT TO THE HOSPITAL FOR ASSISTANCE. AT THE TIME OF HIS HOSPITALIZATION, THE PATIENT INDICATED HE WAS TESTED BY THE ER/HOSPITAL METER (RESULT NOT SPECIFIED), WAS DIAGNOSED FOR "HIGH BLOOD SUGAR", AND WAS TREATED WITH MEDICATION (TYPE/DOSE NOT SPECIFIED). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NOT MISUSED, AND THE CORRECT TEST STRIPS WERE USED. THE METER REQUIRED A NEW BATTERY REPLACEMENT, BUT THE PATIENT DID NOT HAVE ONE READILY AVAILABLE AT THE TIME. 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 A SERIOUS INJURY REQUIRING HCP INTERVENTION 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. 2857763

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R