BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1030024 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00563
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 31, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT# NOT PROVIDED. 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/RPTR (THE PT'S GRANDDAUGHTER) CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS GIVING AN "ERROR" MESSAGE DURING TEST STRIP INSERTION. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PT'S DAUGHTER-IN-LAW (ANOTHER LAY-USER/RPTR) ON NINE DAYS LATER, AND WAS ABLE TO OBTAIN/VERIFY INFO. THE PT TESTS HER BLOOD GLUCOSE AROUND 2-4 TIMES A DAY. SHE TYPICALLY TESTS BEFORE BREAKFAST (7:00 AM), BEFORE BEDTIME (10:00 PM), 1:00 AM, AND 4:00 AM. SHE CURRENTLY TAKES SET DOSES OF 15 UNITS N-INSULIN IN THE MORNING AND EVENING TIME. THE PT'S DAUGHTER-IN-LAW INDICATED THAT THE PT ATE DINNER AS USUAL ON TWO DAYS PRIOR TO ORIGINAL DATE. SHE COULD NOT RECALL WHAT THE PT'S BLOOD GLUCOSE LEVEL WAS BEFORE GOING TO BED THAT NIGHT. AROUND 3:31 AM, THE PT WOKE UP WITH SYMPTOMS OF SWEATING. THE PT'S GRANDDAUGHTER ATTEMPTED TO TEST HER BLOOD GLUCOSE BUT THE ALLEGED ERROR MESSAGE KEPT APPEARING. THE PT'S DAUGHTER-IN-LAW COULD NOT CONFIRM WHAT ERROR MESSAGE APPEARED. ACCORDING TO THE GRANDDAUGHTER, AND FOR AN UNK REASON, THE PT WAS GIVEN OR TOOK AN INCREASED DOSE OF DIABETES MEDICATION AS A RESULT OF THE ALLEGED ISSUE. THE PT APPARENTLY TOOK 35 UNITS OF N-INSULIN AT AN UNK TIME. THE PT'S DAUGHTER-IN-LAW WAS UNABLE TO CONFIRM THIS ACTION. PARAMEDICS WERE CONTACTED AND TESTED THE PT'S BLOOD GLUCOSE AT AN UNK TIME THAT SAME MORNING. THEY OBTAINED A RESULT OF "25 MG/DL" USING AN UNIDENTIFIED DEVICE. THE PARAMEDICS ADMINISTERED 2 GLUCAGON INJECTIONS. BY 4:00 AM, THE PT WAS TESTED AT AN ER WHERE HER BLOOD GLUCOSE LEVEL WAS "87 MG/DL". AT 4:45 AM, HER BLOOD GLUCOSE APPARENTLY DROPPED TO "36 MG/DL." AT 5:15 AM, HER BLOOD GLUCOSE WENT BACK UP TO "198 MG/DL" AND AT 6:45 AM IT WAS "167 MG/DL". THE PT WAS HOSPITALIZED FOR 3 DAYS TO STABILIZE HER BLOOD GLUCOSE. AS A RESULT OF THE EVENT, THE PT'S DR MODIFIED THE PT'S INSULIN REGIMEN FROM 25 UNITS EVERY MORNING TO 15 UNITS BEFORE BREAKFAST AND BEDTIME. 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 RPTR CLAIMED THE PT TOOK AN INCREASED DOSE OF N-INSULIN AFTER THE REPORTED METER ISSUE BEGAN AND OBTAINED A BLOOD GLUCOSE READING OF "36 MG/DL" AT 1.25 HRS LATER.

    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 84 YR Hospitalization| L