BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1163086 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02253
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PT TESTS BLOOD GLUCOSE TWICE A DAY. HE TAKES INSULIN (UNKNOWN TYPE) ONCE A DAY IN THE EVENING. HE ALSO TAKES GLUCOVANCE. THE REPORTER STATED THAT THE PT HAD BEEN HOSPITALIZED FOR 59 DAYS DUE TO AN UNSPECIFIED REASON. HE HAD JUST BEEN DISCHARGED FROM THE HOSPITAL ON FOUR DAYS PRIOR TO ORIGINAL DATE. THE REPORTER INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THREE DAYS PRIOR TO ORIGINAL DATE, AT AROUND 8:00 AM. BEFORE THE ALLEGED METER ISSUE BEGAN, THE PT REPORTEDLY HAD SYMPTOMS OF FEELING SHAKY. THE REPORTER TREATED THE PT WITH ORANGE. ALSO, ON ORIGINAL DATE, DURING THE MORNING TIME AT 8:00 AM, THE REPORTER CLAIMED THAT SHE HAD TO GIVE HIM ORANGE JUICE AND A DONUT SINCE HIS BLOOD GLUCOSE WAS "LOW". THE PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED ON ANOTHER METER AT THE TIME AND A RESULT OF "49 MG/DL" WAS OBTAINED. THE OTHER METER BELONGED TO THE REPORTER'S DAUGHTER. THE REPORTER MENTIONED THAT AFTER THE ALLEGED METER ISSUE BEGAN. THE PT STARTED TESTING HIS BLOOD GLUCOSE WITH HER DAUGHTER'S METER. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: IF THE PT WAS SYMPTOMATIC ON ORIGINAL DATE, BEFORE HE WAS TREATED WITH THE ORANGE JUICE AND DONUT, IF HE WAS ABLE TO TEST BEFORE THE SYMPTOMS DEVELOPED, WHY HE WAS TREATED WITH THE ORANGE JUICE AND DONUT, AND WHAT HIS LAST BLOOD GLUCOSE READING WAS BEFORE THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PT WAS ABLE TO TEST HIS BLOOD GLUCOSE ON FOUR DAYS PRIOR TO ORIGINAL DATE, AND WHAT ACTIONS HE TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. WHILE SPEAKING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE REPORTER WAS ABLE TO TURN THE METER ON. HOWEVER, THE DEVICE DISPLAYED A BATTERY INDICATOR SYMBOL. SHE DID NOT HAVE A REPLACEMENT BATTERY ON HAND FOR TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT SHE HAD TO TREAT THE PT WITH FOOD AND A BEVERAGE AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT CLEAR IF THE PT HAD DEVELOPED SYMPTOMS ON THE SECOND REPORTED EVENT (ORIGINAL DATE) AND IF HE WAS ABLE TO TEST BEFORE RECEIVING THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2823264

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R