BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2604636 · Received June 8, 2012

    Report

    Report Number
    2939301-2012-06214
    Event Type
    Injury
    Date Received
    June 8, 2012
    Report Date
    June 6, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER'S BATTERY WAS FOUND TO HAVE A LOW VOLTAGE. 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) 2012,THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY A YEAR AGO PRIOR TO CONTACTING LFS. IT WAS NOTED THAT THE ISSUE WITH THE SUBJECT METER WAS NOT REPORTED AS SHE HAD A BACK UP METER SHE WAS USING UNTIL IT STOPPED WORKING ABOUT 2 MONTHS AGO AND WAS RELUCTANT TO CALL. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON AN INSULIN. DESPITE THE ALLEGED POWER ISSUE, THE PATIENT STATED SHE CONTINUED HER USUAL MORNING AND NIGHT DOSE OF "NHP AND TORONTO." IT WAS NOTED BY THE CSR, THAT THE PATIENT DEVELOPED SYMPTOMS OF "SHAKING" AFTER THE ALLEGED ISSUE BEGAN; HOWEVER, NO TREATMENT/MEDICAL INTERVENTION WAS RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT A 1ST TIME USER OF THE SUBJECT METER, THERE WAS NO MISUSED OF THE METER, THE CORRECT TEST STRIPS WERE USED, AND THE METER REQUIRED NEW BATTERIES; WHICH WERE NEVER CHANGED. THE PATIENT, HOWEVER, DID NOT HAVE NEW BATTERIES AND TEST STRIPS AVAILABLE TO POWER THE METER ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening