BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1173434 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02355
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRAMINI METER HAD AN "ERROR 5" ISSUE AND WAS READING INACCURATELY. THE PT TESTS HER BLOOD GLUCOSE 2-3 TIMES A DAY. SHE TYPICALLY TESTS BEFORE MEALS. BEFORE THE REPORTED EVENT OCCURRED, THE PT WAS TAKING METFORMIN AND AMARYL. CURRENTLY, THE PT IS TAKING METFORMIN AND ACTOS. SHE DOES NOT ADJUST HER MEDICATION DOSAGES BASED ON HER METER READINGS. THE PT INDICATED THAT THE ALLEGED METER ISSUES STARTED ON TWO DAYS EARLIER, AT AN UNSPECIFIED TIME. THE PT EXPLAINED THAT THE METER WAS INTERMITTENTLY GIVING "ERROR 5" MESSAGES. SHE STATED THAT AT TIMES, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE BECAUSE OF THE "ERROR 5" MESSAGES. WHENEVER THE PT WAS ABLE TO GET A METER READING, THE PT CLAIMED THAT THE METER SHOWED READINGS SUCH AS "45, 51, AND 59 MG/DL." SHE WAS UNABLE TO PROVIDE THE DATES/TIMES THAT THE RESULTS WERE OBTAINED. ON ORIGINAL DATE, AT AROUND 2:00 PM, THE PT MENTIONED THAT SHE STARTED FEELING SHAKY AND HAD A HEADACHE. THE PT COULD NOT RECALL IF SHE WAS ABLE TO TEST HER BLOOD GLUCOSE EARLIER IN THE DAY PRIOR TO DEVELOPING THE SYMPTOMS. AFTER THE SYMPTOMS DEVELOPED, THE PT CALLED HER DOCTOR. A NURSE REPORTEDLY ADVISED THE PT TO DECREASE HER METFORMIN MEDICATION DOSAGE FROM 4 MG TO 2 MG IN THE MORNING. SHE WAS ALSO ADVISED BY THE NURSE TO EAT SOMETHING. THE PT'S BLOOD GLUCOSE WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE PT WAS UNABLE TO REMEMBER ADDITIONAL DETAILS OF THE EVENT. THE ALLEGED "ERROR 5" ISSUE WAS RESOLVED AFTER THE PT RETESTED WITH A NEW VIAL OF TEST STRIPS. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. 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 ALSO CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AT TIME BECAUSE OF THE ALLEGED "ERROR 5" ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE METER WAS READING INACCURATELY WHENEVER SHE WAS ABLE TO TEST DURING THE TIME OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2737058

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R