BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH VITA METER

    MDR report key: 1211546 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02749
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    LIFESCAN, INC
    Product Code
    NBW
    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 EVALUATION, 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 STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN (LFS) IN 2008 INQUIRING AN OWNER'S BOOKLET FOR HIS ONE TOUCH VITA METER. DURING THE CALL, HE MENTIONED THAT HE HAD AN HYPOGLYCEMIC EPISODE ON TWO DAYS EARLIER. THE PT HAS BEEN USING THE ONE TOUCH PROFILE METER FOR YEARS AND ONLY A FEW DAYS AGO, HE PURCHASED THE OT VITA METER AND STARTED USING THE METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFO: ON THAT DAY AT 8:00AM, HE TESTED HIS BLOOD GLUCOSE AND REPORTEDLY OBTAINED A 7.5MMOL/L (135MG/DL). DUE TO THE READING, HE TOOK 20 UNITS OF ACTRAPID INSULIN AND 14 UNITS OF PROTAFANE. HE ATE BREAKFAST (A COUPLE OF SLICES OF BREAD WITH JAM AND CURD CHEESE WITH CRISPBREAD). HE ATE SOME SOUP AROUND 12:30 PM. THE ONLY READING THE PT TOOK THAT DAY WAS THE MORNING READING OF 7.5 MMOL/L. AT 2:30 PM, HE WAS READING THE NEWSPAPER AND NOTICED THAT THE FONT ON THE NEWSPAPER WAS BLURRY. HIS WIFE WAS ON VACATION AND TRIED TO CALL HER HUSBAND AND WAS UNSUCCESSFUL. AT 4:30 PM, SHE CONTACTED HER DAUGHTER TO FIND OUT WAS GOING ON. DAUGHTER DROVE TO HER FATHER'S HOUSE AND REPORTEDLY FOUND HIM UNCONSCIOUS AT 5:00PM AND CONTACTED THE EMERGENCY SERVICES. EMERGENCY DOCTOR TESTED THE PT AND REPORTEDLY OBTAINED A 66 MG/DL AND TREATED HIM WITH TWO AMPULES OF GLUCOSE. THE PT REGAINED CONSCIOUSNESS SHORTLY AFTER TREATMENT. THE EMERGENCY DOCTOR WANTED TO TAKE HIM TO THE HOSPITAL; HOWEVER, THE PT REFUSED TO GO. THE PT'S BLOOD GLUCOSE WAS TESTED ON THE EMERGENCY PHYSICIAN'S METER AND OBTAINED AN 86 MG/DL. EMERGENCY DOCTOR THEN PHONED THE PT'S DIABETES DOCTOR AND ARRANGED AN APPOINTMENT. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PT DID NOT HAVE ANY CONTROL SOLUTION. A NORMAL READING FOR THE PT IS AROUND 6.1MMOL/L TO 7.8 MMOL/L. ALL PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY TOOK INSULIN BASED ON THE ALLEGED HIGH READING AND FELL UNCONSCIOUS A COUPLE HOURS LATER. THE PT WAS ALLEGEDLY TREATED FOR HYPOGLYCEMIA AND REGAINED CONSCIOUSNESS SHORTLY AFTER TREATMENT BY A MEDICAL PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC NA 2852208

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R