BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1013144 · Received March 12, 2008

    Report

    Report Number
    2939301-2008-00294
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 20, 2008
    Report Date
    February 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVAL, 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/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE REPORTER INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE MONTH BEFORE. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT TOOK HIS USUAL DOSAGE(S) OF MEDICATION(S) FOR DIABETES. ON AN UNSPECIFIED DATE/TIME DURING THE TIME OF CONCERN, THE PT DEVELOPED SYMPTOMS OF SWEATS, SHIVERS, LOSS OF BALANCE, AND A DRY MOUTH. ON A WEEK LATER, THE PT RECEIVED ASSISTANCE IN AN EMERGENCY ROOM (ER). THE PT'S BLOOD GLUCOSE WAS TESTED ON AN ER/HOSP METER AND RESULTS OF "40, 70, AND 62 MG/DL" WERE REPORTEDLY OBTAINED. THE PT WAS TREATED WITH IV GLUCOSE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MGMT REGIMENS, WHAT DATE/TIME THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PT TOOK BEFORE, DURING, AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHY THE PT WENT TO THE ER AND HOW LONG THE PT REMAINED AT THE HOSP. THE REPORTED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF ABNORMAL BLOOD GLUCOSE LEVEL DURING THE TIME OF CONCERN. THE INFO PROVIDED SUGGESTS THE PT MAY HAVE BEEN UNABLE TO TEST HIS BLOOD GLUCOSE FOR SEVERAL DAYS AND ULTIMATELY RECEIVED IV GLUCOSE TREATMENT IN AN ER.

    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 62 YR Hospitalization| L| R