BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2418524 · Received January 17, 2012

    Report

    Report Number
    2939301-2012-00616
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Report Date
    January 10, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/13/2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEAD/LOW BATTERY ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE METER RETAIN OF THE SAME LOT# HAS PASSED ALL TESTING WITH NO FAULTS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND AFTER THE BATTERY WAS REPLACED. 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

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ON (B)(6) 2012 ALLEGING THAT THEIR ONE TOUCH ULTRAEASY METER WOULD NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE COMPLAINT WAS CLASSIFIED BASED ON THE INITIAL CALL PLACED ON (B)(6) 2012. THE PATIENT MENTIONED THAT ON (B)(6) 2011 AT AROUND 7:30AM, HER METER WOULD NOT POWER ON. DUE TO THE ALLEGED ISSUE A COUPLE OF DAYS LATER, THE PATIENT DEVELOPED "LOW BLOOD SUGAR" AND SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PATIENT IS USING THE PRODUCT. THERE WAS NO MISUSE OF THE PRODUCT. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON. THE BATTERY NEEDED TO BE REPLACED; HOWEVER, THE PATIENT DID NOT HAVE REPLACEMENT BATTERY. THE PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, EXACT SYMPTOMS, CONFIRM WHETHER THE PATIENT DID NOT SELF-TREAT, AND HOW LONG SYMPTOMS LASTED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE DEVELOPED "LOW BLOOD SUGAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3207821

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening