BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1032810 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00606
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    April 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE PT TESTS HER BLOOD GLUCOSE 3 TIMES A DAY. SHE TAKES GLUCOPHAGE. THE PT WAS UNABLE TO PROVIDE THE DETAILS OF HER MEDICATION REGIMEN. THE PT COULD NOT RECALL WHEN THE REPORTED METER ISSUE BEGAN AND WAS UNABLE TO PROVIDE AN ESTIMATE AS TO THE DURATION OF THE ISSUE. ALTHOUGH THE PT WAS UNABLE TO TEST HER BLOOD GLUCOSE, THE PT CONTINUED TO TAKE HER GLUCOPHAGE MEDICATION AS PRESCRIBED. ON AN UNSPECIFIED DATE/TIME AFTER THE REPORTED ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS OF SHAKINESS. THE PT TRIED TO TEST HER BLOOD GLUCOSE BUT THE METER WAS NOT POWERING ON. THE PT WENT TO AN EMERGENCY ROOM (ER) BECAUSE OF THE SYMPTOMS. THE PT CLAIMED THAT HER BLOOD GLUCOSE WAS NOT CHECKED BY THE ER AND THAT SHE DID NOT RECEIVE ANY MEDICAL TREATMENT. WHEN THE PT GOT HOME FROM THE ER, SHE ATE FRUIT AND FELT BETTER. DURING TROUBLESHOOTING, THE PT WAS ABLE TO TURN THE METER ON WITHOUT ANY ISSUES. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PT ALLEGED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE BECAUSE OF THE METER ISSUE FOR AN UNK PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R