BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1211542 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02751
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 20, 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 METER AND STRIPS 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 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/PATIENT CONTACTED LFS ALLEGING THAT HER ONE TOUCH ULTRAEASY METER STOPPED WORKING IN 2008 BECAUSE THE TEST STRIP PORT FELT TIGHT AND SCRATCHED THE TEST STRIP WHEN IT WAS INSERTED INTO THE METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE PT WAS UNABLE/UNWILLING TO ANSWER ANY OF THE FOLLOW UP QUESTIONS. ON TEN DAYS LATER, THE PT WENT TO HER SON'S HOUSE FOR DINNER AND ATE A VEGAN DIET AND JUST ATE SALAD. AT 8PM WHEN SHE WENT TO BED, SHE INJECTED 8 UNITS OF INSULATARD INSULIN. SHE ADJUSTS HER INSULIN ACCORDING TO WHAT SHE EATS. SHE NORMALLY HAS 1-2 UNITS IN THE MORNING AND BETWEEN 6 - 16 UNITS IN THE EVENING DEPENDING ON HER MEAL. AT AN UNSPECIFIED TIME THE FOLLOWING MORNING, HER SON REPORTEDLY FOUND HER FACE DOWN ON THE FLOOR. HE TREATED HER WITH 3-4 SPOONS OF HONEY AND AT AN UNSPECIFIED TIME LATER, SHE REGAINED CONSCIOUSNESS. SHE DID NOT HAVE HER METER WITH HER DUE TO THE ALLEGED ISSUE AND HAD NOT TESTED HER BLOOD GLUCOSE FOR 10 DAYS PRIOR TO THE INCIDENT. THE PT FELT FINE AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ADVICE. HER SON TOOK HER HOME LATER THAT DAY. THE FOLLOWING DAY, HER SON CALLED HER AT HOME AND THE PT DID NOT ANSWER HIS CALLS; THEREFORE HE CONTACTED THE PARAMEDICS. PARAMEDICS ARRIVED TO THE PT'S HOME AND SHE OPENED THE DOOR FOR THEM. THEY TESTED HER BLOOD GLUCOSE ON THEIR DEVICE; HOWEVER, DID NOT RECALL THE READING. PT MENTIONED THAT THE BLOOD GLUCOSE READING WAS "VERY LOW", SO THE TREATED HER WITH A CLEAR LIQUID FROM A TUBE. THEY TRANSPORTED THE PT TO THE HOSPITAL, WHERE SHE WAS TREATED WITH AN UNK DRIP AND GIVEN A MEAL, AND A CUP OF TEA. HER BLOOD GLUCOSE WAS TESTED THROUGHOUT THE DAY; HOWEVER, THE PT DID NOT RECALL BLOOD GLUCOSE READINGS IN THE HOSPITAL. SHE WAS DISCHARGED LATER THAT NIGHT AROUND 9:00PM. SINCE THE INCIDENT THE PT HAD BEEN USING A FREESTYLE METER; HOWEVER, THE BATTERIES RECENTLY WERE DEAD. THE METER IS NOT A NEW PRODUCT (OUT OF BOX). PT HAS HAD THE SUBJECT METER SINCE FOUR MONTHS EARLIER. NO FURTHER CLINICAL INFO WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT A NORMAL READING IS FOR THE PT, WHAT KIND OF READINGS THE PT HAD BEEN OBTAINING ON THE FREESTYLE METER AND WHY THE PT WAITED SO LONG TO CONTACT LFS FOR ASSISTANCE. CUSTOMER CARE ADVOCATE (CCA) SENT THE PT REPLACEMENT METER, STRIPS AND CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE THE PT REPORTED SHE WAS UNABLE TO OBTAIN A READING DUE TO THE ALLEGED ISSUE FOR 10 DAYS AND TOOK INSULIN BASED ON WHAT SHE ATE AND DEVELOPED HYPOGLYCEMIC SYMPTOMS. THE PT FELT BETTER AFTER TREATMENT. THE PT WAS ALSO TAKEN TO THE HOSPITAL THE FOLLOWING DAY, DUE TO LOW BLOOD GLUCOSE AND WAS TREATED FOR 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 2851334

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R