BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2060374 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03138
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. PRODUCT ANALYSIS FOUND THE METER'S LCD CABLE/CABLE CONNECTOR WAS DEFECTIVE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER HAS SEGMENTS MISSING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 8:00AM. AS PART OF HER DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON ORAL MEDICATION OF METFORMIN 500MG. AN HOUR BEFORE THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE ADMINISTERED HER USUAL DOSE OF ORAL MEDICATION. BY 12:00PM THAT DAY, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKINESS. AN HOUR AFTER HER SYMPTOM, THE PATIENT INDICATED SHE TOOK AN INCREASED DOSE OF METFORMIN PILLS. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER TO THE SUBJECT METER AND THAT THERE WAS NO MISUSED OF THE METER. 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026331

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R