BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1030744 · Received April 17, 2008

    Report

    Report Number
    2939301-2008-00586
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 EVAL, BUT HAS NOT YET REC'D 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 READ INACCURATELY HIGH. THE PT TESTS HIS BLOOD GLUCOSE 4-6 TIMES A DAY. HE TAKES SLIDING-SCALE HUMALOG INSULIN IN THE EVENING BASED ON HIS METER READINGS. ON TWO DAYS EARLIER, THE PT OBTAINED A METER READING OF "202 OR 207 MG/DL" AROUND 9:00 PM. HE INDICATED THAT THE RESULT DID NOT SEEM TO BE ABNORMALLY HIGH FOR HIM. BASED ON THE METER READING, HE TOOK 10 UNITS OF HUMALOG INSULIN. ABOUT 2 HOURS LATER, AROUND 10:00 OR 11:00 PM, THE PT'S FINANCE HEARD SOME COMMOTION IN THE BATHROOM. SHE FOUND THE PT PASSED OUT ON THE FLOOR. SHE TESTED HIS BLOOD GLUCOSE WITH THE REPORTED METER AT THAT POINT AND GOT A RESULT OF "40 MG/DL." SHE THEN TREATED HIM WITH MILK AND BROWN SUGAR, AND ALSO 3 TUBES OF GLUCOSE GEL. THE TREATMENT HELPED TO RELIEVE HIS SYMPTOMS. THE PT STATED THAT THE SAME THING HAPPENED THE NEXT DAY, BUT HE WAS UNWILLING TO PROVIDE FURTHER INFO REGARDING THE EVENT. THE PT JUST EXPLAINED THAT HE GOT ANOTHER HIGH READING IN THE EVENING, TOOK INSULIN BASED ON THE METER READING, AND SUFFERED FROM "INSULIN SHOCK." THE PT DENIED SEEKING OR RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. HE WAS ALSO NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. HE DID NOT HAVE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE SUFFERED "INSULIN SHOCK" TWO TIMES AND PASSED OUT AFTER TAKING SLIDING-SCALE INSULIN BASED ON THE METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2770238

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R