BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1883709 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09525
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    October 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 K053529.

    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. THE METER WAS FOUND TO HAVE CAPACITOR FAILURE. A SECONDARY ISSUE WAS ALSO NOTED AS BATTERY LOW/DEAD. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER PROMPTS THE BATTERY INDICATOR. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT RECALL WHEN THE ALLEGED IS BEGAN. THE PATIENT STATED HE DOES NOT MANAGE HIS DIABETES WITH ORAL MEDICATION OR INSULIN. IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HIS DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE AND IT IS ALSO NOT KNOWN IF THE PATIENT TESTED WITH ANOTHER DEVICE. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF DIZZINESS AND BLURRY VISION AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT, HOWEVER, DENIED RECEIVING MEDICAL INTERVENTION OR TREATMENT AFTER THE REPORTED METER ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THERE WAS NO MISUSE OF THE LFS PRODUCT AND NOTED THAT WITHIN THE YEAR, THE PATIENT REPLACED THE BATTERIES IN THE SUBJECT METER THREE TO FOUR TIMES. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR CLOSING A TREPANATION, A BEEP SOUND WAS HEARD AFTER A FEW ACTUATIONS AND THE DEVICE WAS STOPPED BEING USED ONCE. WHEN THE DEVICE WAS ACTIVATED AGAIN AFTER A WHILE, THE BLADE WAS BROKEN OFF (RETRIEVED). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR WAS USED TO USING HARMONIC INSTRUMENTS AND COMMENTED THAT THE DEVICE HAD NOT BEEN ACTIVATED IN TOUCHING A FORCEPS.

    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 65 YR Life Threatening