BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1051872 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00853
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, INT'L AFFILIATE RECEIVED AN UNAUTHORIZED RETURN OF A ONE TOUCH ULTRA EASY METER AND CONTACTED THE PT TO OBTAIN ADDITIONAL INFO ABOUT THE RETURN. THE PT IN TURN ALLEGED THE ONE TOUCH ULTRA EASY METER WAS READING INACCURATELY HIGH. THE PT STATED THAT WHEN HE COMPARED HIS ULTRA EASY METER TO HIS OTHER METER, THE RESULTS ON THE ULTRA EASY WERE ALWAYS HIGHER. THE PT SAYS HE THINKS THE METER HAD BEEN READING HIGH FOR ABOUT 5 TO 10 DAYS BUT DID NOT PROVIDE HIS PREVIOUS RESULTS. ABOUT 4 DAYS PRIOR TO RETURN OF THE METER AT 10 PM, THE PT OBTAINED A READING OF 220 MG/DL ON HIS ULTRA EASY METER. HE STATES HIS NORMAL READINGS AROUND THAT TIME ARE 100-120 MG/DL. AT THAT TIME, HE INJECTED 8 UNITS OF LANTUS INSULIN, 4 MORE UNITS THAN HIS NORMAL DOSE AND WENT TO BED. AT AN UNKNOWN TIME DURING THE NIGHT, THE PATIENT WOKE UP FEELING DIZZY AND SWEATY. AT THAT TIME, HE TESTED HIS BLOOD SUGAR ON HIS OTHER METER AND OBTAINED A RESULT OF 45 MG/DL. THE PT DRANK SOME APPLE JUICE AND WAITED IN THE KITCHEN UNTIL HE FELT BETTER. THE PT WAS UNABLE TO TELL LIFESCAN HOW LONG IT TOOK FOR HIM TO FEEL BETTER. AFTER HE FELT BETTER, HE WENT BACK TO BED. HE DID NOT TEST HIS BLOOD SUGAR WITH THE ULTRA EASY METER AT THAT TIME. IN ADDITION TO TAKING 4 UNITS OF INSULIN BEFORE GOING TO BED, THE PT ALSO TAKES 6 UNITS OF NOVORAPID BEFORE BREAKFAST. LUNCH, AND DINNER. THE PT HAS A SLIDING SCALE FOR HIS INSULIN BUT DOES NOT USE IT AND INSTEAD RELIES ON HIS PERSONAL JUDGEMENT ACCORDING TO THE METER READINGS TO ADJUST HIS DOSE OF INSULIN. WHEN HE HAS ABNORMALLY HIGH READINGS, HE TAKES EXTRA INSULIN BUT WAS UNABLE TO PROVIDE AN EXACT SCALE. THE PT TESTS HIS BLOOD SUGAR 4 TIMES PER DAY. HE DID NOT ADJUST HIS DIET BEFORE HE WOKE UP WITH SYMPTOMS AND SAYS HE EATS NEARLY THE SAME AMOUNT EVERY DAY. THE PT HAS BEEN USING HIS OTHER METER AS HIS PRIMARY METER SINCE THE TIME HE HAD SYMPTOMS. BEFORE HE HAD THE SYMPTOMS, HE USED THE ULTRA EASY METER AS HIS PRIMARY METER. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THE PT'S TESTING TECHNIQUE WAS CORRECT, AND THE PT CLEANED THE PUNCTURE AREA CORRECTLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED HE HAD AN INACCURATE HIGH READING, TOOK ADDITIONAL INSULIN BASED ON THAT READING, AND EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R