BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH EUROFLASH METER

    MDR report key: 1104827 · Received August 8, 2008

    Report

    Report Number
    2939301-2008-01774
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STIRPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STIRPS 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/PT VACATIONING CONTACTED LIFESCAN ALLEGING THE EUROFLASH METER PROMPTED AND ERROR 2 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST WROTE FOLLOW UP QUESTIONS TO THE TECHNICAL SERVICE REPRESENTATIVE FOR CLARIFICATION. THE TECHNICAL SERVICE REPRESENTATIVE MENTIONED THE PT LIVES IN OTHER COUNTRY, AND DOES NOT SPEAK THE LANGUAGE CLEARLY. THE PT STATES HE HAS BEEN ON VACATION SINCE THREE DAYS EARLIER. HE TOOK HIS TWO BACKUP EUROFLASH METERS WITH HIM ON VACATION IN SAINT TROPEZ. HE ALSO HAS A PRIMARY METER (A ONE TOUCH ULTRA) THAT HE LEFT AT HOME IN MONACO. ONE OF THE BACKUP METERS REPORTEDLY PROMPTED THE ERROR 2 MESSAGE AND THE OTHER GAVE THE PT READINGS. THE PT REPORTEDLY USED EXPIRED TEST STRIPS TO TEST HIS BLOOD SUGAR. THE PT TAKES 26 UNITS OF LANTUS AND 4 UNITS OF ACTRAPID INSULIN IN THE MORNING ON A NORMAL BASIS. HE IS TOLD TO INCREASE HIS DOSE IF THE RESULT IS ABOVE 150 MG/DL. WHEN HIS RESULT IS TOO LOW (UNDER 80 MG/DL) THE PT EATS MORE OR HAS SUGAR. THE PT TESTS HIS BLOOD SUGAR 6 TO 8 TIMES PER DAY. ON THE DAY PRIOR TO ORIGINAL DATE, THE PT ATE A SANDWICH AT LUNCH AROUND 1 PM, WHICH IS REPORTEDLY LESS THAN USUAL FOR HIM. THE PT WAS ON BOAT AT THAT TIME. THE PT SAYS HE FELL INTO THE SEA AFTER LUNCH AT AROUND 4 PM. HE HAD INTENDED TO GO INTO THE SEA SLOWLY DOWN A LADDER. THEN HE GOT OUT OF THE SEA ALTHOUGH IT WAS NOT SPECIFIED HOW HE GOT OUT OF THE SEA. AFTER THIS INCIDENT, HIS FRIEND GAVE HIM SOME SODA TO DRINK BECAUSE HE KNEW THE PT WAS DIABETIC AND MIGHT HAVE BEEN HYPOGLYCEMIC. THE PT WAS NOT ABLE TO DESCRIBE HIS SYMPTOMS CLEARLY BUT SAID HE FELT CONFUSED AND DIZZY, "AS IF HE WAS NOT AS CONSCIOUS OF HIS SURROUNDINGS AND WHAT HE WAS DOING". HE SAID HE MIGHT HAVE BEEN HYPOGLYCEMIC BUT HE IS NOT QUITE SURE. HE HAD REPORTEDLY TAKEN THE METER THAT HAD THE ERROR 2 MESSAGE WITH HIM ON THE BOAT INSTEAD OF THE ONE THAT GAVE HIM RESULTS. THEREFORE, HE REPORTEDLY WAS NOT ABLE TO TEST BEFORE LUNCH THAT DAY OR BEFORE HE FELL INTO THE SEA. HE DID ALLEGEDLY GET A READING IN THE MORNING BEFORE HE WENT ON THE BOAT OF 145 MG/DL ON THE METER THAT GAVE HIM READINGS. FOR THREE DAYS IN 2008, THE PT WAS REPORTEDLY ABLE TO TEST HIS BLOOD SUGAR ON HIS OTHER EUROFLASH METER ALTHOUGH HE WAS USING EXPIRED TEST STRIPS. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE TEST STRIPS WERE EXPIRED AND THE ERROR 2 MESSAGE OCCURRED WHEN INSERTING THE TEST STRIP RATHER THAN PRESSING THE POWER BUTTON. THE METER WAS NOT NEW. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED HE COULD NOT TEST DUE TO THE ERROR 2 MESSAGE, MAY HAVE ADJUSTED HIS TREATMENT BASED ON THE METER READINGS, AND LATER, ALLEGED THAT HE MAY HAVE BEEN EXPERIENCING HYPOGLYCEMIC SYMPTOMS, WHICH MAY HAVE CONTRIBUTED HIM TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH EUROFLASH METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2517251

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R