BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1023304 · Received April 1, 2008

    Report

    Report Number
    2939301-2008-00436
    Event Type
    Injury
    Date Received
    April 1, 2008
    Report Date
    March 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER HAD A CALCODE ISSUE. THE PT TESTS HIS BLOOD GLUCOSE 4 OR MORE TIMES A DAY. HE TAKES UNSPECIFIED PILLS FOR HIS DIABETES. THE PT INDICATED THAT THE METER WAS NOT WORKING BECAUSE THE DEVICE WAS NOT CODED PROPERLY. APPARENTLY, THE PT WAS UNABLE TO CODE THE METER. IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE BEGAN. HOWEVER, THE PT'S WIFE CLAIMED THAT HE HAD BEEN TO AN ER 5 TIMES WITHIN THE PAST 5 MONTHS BECAUSE OF THE METER. THE PT REPORTEDLY RECEIVED UNSPECIFIED INTRAVENOUS TREATMENT. THE PT DENIED HAVING ANY SYMPTOMS OF HIGH/LOW BLOOD GLUCOSE DURING THE TIME OF CONCERN. THE PT'S BLOOD GLUCOSE WAS TESTED ON A DOCTOR'S/CLINIC'S METER, BUT THE RESULTS OBTAINED WERE NOT PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOWN THE FOLLOWING INFO: WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE, IF THE PT WAS TESTING WITH THE METER DURING THE TIME OF CONCERN, WHAT METER READINGS HE WAS GETTING, AND THE DETAILS OF HIS DIABETES MANAGEMENT REGIMEN. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT OTHER HEALTH CONDITIONS THE PT HAS, WHY THE PT WENT TO THE ER EACH TIME, AND WHY HE RECEIVED IV TREATMENT. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT'S WIFE CLAIMED THAT HE RECEIVED IV TREATMENT AND WAS SEEN IN AN ER FIVE TIMES WITHIN THE PAST 5 MONTHS BECAUSE OF THE METER. IT IS NOT KNOWN HOW LONG THE PT WAS UNABLE TO CODE THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2788135

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R