BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1222085 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02935
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    June 30, 1905
    Report Date
    October 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT IN THE CONTACTED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONETOUCH ULTRAEASY METER WAS GIVING INACCURATE RESULTS. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT THE FOLLOW-UP QUESTION TO THE CUSTOMER SERVICE AGENT (CSA) TO ASK THE PT AND VERIFIED THE FOLLOWING INFO. THE PT REPORTED BLOOD GLUCOSE RESULTS OF "29.1 MMOL/L" WITH A LIFESCAN METER AND "21.6MMOL/L" ON ANOTHER METER, PERFORMED WITHIN 10 MINS OF EACH OTHER. BASED ON STATICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30%. THE PT INDICATED THAT ON AN UNK DATE AT AROUND 11:00 PM, HE RECEIVED A RESULT OF 16.0 MMOL/L. HE MENTIONED THAT HE WAS ASYMPTOMATIC AT THAT TIME. HE TOOK UNK DOSAGE OF LEVEMIR INSULIN BASED ON HIS BLOOD SUGAR READING THAT NIGHT. AT AROUND 3:00 AM, HE ALLEGEDLY EXPERIENCED "SHAKINESS AND HEADACHE". HE TESTED HIS BLOOD SUGAR ON THE ALLEGED METER AND RECEIVED A RESULT OF 3.0 MMOL/L. HE DRANK SOME "LUCOZADE" AND FELT BETTER IN ABOUT TWO MINS. ON THE SAME DAY LFS WAS CONTACTED IN THE EVENING, HE TESTED HIS BLOOD SUGAR ON THE ALLEGED METER AND RECEIVED A RESULT OF 29.1 MMOL/L. THEN, HE TESTED HIS BLOOD SUGAR ON ANOTHER METER AND RECEIVED A RESULT OF 21.6 MMOL/L. HE ADMINISTERED ABOUT 20 UNITS OF NOVARAPID INSULIN INSTEAD OF A USUAL DOSE OF 28 UNITS BASED ON THE READING OF 21.6 MMOL/L TAKEN ON ANOTHER DEVICE. HE MENTIONED THAT HE DID NOT EXPERIENCE ANY SYMPTOM THEREAFTER. THE CUSTOMER SERVICE AGENT (CSA) DISCOVERED THAT THE PT WAS USING CORRECT TECHNIQUE TO TEST AND TO CLEAN THE PUNCTURE AREA, THE SAMPLE WAS DRAWN FROM AN APPROVED SOURCE, THE UNIT OF MEASURE WAS SET CORRECTLY, THE SAMPLE WAS DRAWN FROM AN APPROVED SOURCE, THE TEST STRIPS SEEMED TO BE IN GOOD CONDITION AND THE METER WAS CODED PROPERLY. QUALITY CONTROL TESTING WAS NOT PERFORMED, AS THE PT'S CONTROL SOLUTION WAS EXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, DUE TO THE FOLLOWING CONCLUSION: THE PT HAD ALLEGEDLY TAKEN AN UNK DOSAGE OF LEVEMIR INSULIN BASED ON A READING RECEIVED ON THE ALLEGED METER AND LATER, EXPERIENCED "SHAKINESS AND HEADACHE", THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT. DIABETES CARE MANAGEMENT: THE PT NORMALLY TESTS HIS BLOOD SUGAR FIVE TIMES DAILY, AT BREAKFAST TIME, 11:00 AM, 1:00 PM, 7:00PM AND 11:00 PM. HE NORMALLY TAKES A SET AMOUNT OF LEVEMIR INSULIN, 40 UNITS AT AROUND 11:00AM AND ADJUSTS DOSAGE OF LEVEMIR INSULIN BASED ON THE METER READINGS AT AROUND 11:00 PM. HE ALSO TAKES NOVORAPID INSULIN BASED ON HIS METER READINGS AND FOOD INTAKE AT LUNCH-TIME, IN THE AFTERNOON AND AT DINNER-TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2863458

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R