BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 767816 · Received October 6, 2006

    Report

    Report Number
    2939301-2006-01380
    Event Type
    Injury
    Date Received
    October 6, 2006
    Report Date
    September 27, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES 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 LIFESCAN (LFS) IN 2006 REGARDING THE ONE TOUCH ULTRA 2 REPLACEMENT PROGRAM. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT WAS FRUSTRATED AND WAS VERY BUSY, CUSTOMER CARE ADVOCATE (CCA) WAS ONLY ABLE TO ASK A COUPLE QUESTIONS. THE PATIENT HAS GESTATIONAL DIABETES AND TEST HER BLOOD GLUCOSE SIX TIMES A DAY AND IS ON INSULIN. THE PATIENT CALLED ALLEGING THAT SHE MAY HAVE HAD AN ISSUE WITH THE DECIMAL POINT; HOWEVER, IS UNSURE. THE PATIENT HADE AN APPOINTMENT AT THE CLINIC 4 WEEKS AGO, AND WAS 33 WEEKS PREGNANT AT THE TIME OF THE VISIT. THE PATIENT TESTED PRIOR TO GOING TO THE APPOINTMENT; HOWEVER, DID NOT RECALL THE READING. AT AN UNSPECIFIED TIME, THE PATIENT TOOK HER ORAL MEDICATION AFTER USING THE METER. WHILE IN THE WAITING ROOM AT THE CLINIC, SHE FELT DIZZY, SWEATY AND EXPERIENCED BLURRED VISION. SHE WAS NOT EDUCATED ON THE SYMPTOMS OF HYPOGLYCEMIA AT THE TIME, AND THOUGHT THE SYMPTOMS WERE RELATED TO HER PREGNANCY. THE NURSE EDUCATED THE PATIENT ON THE SYMPTOMS OF HYPOGLYCEMIA. THE NURSE "QUERIED WHETHER THERE SHOULD HAVE BEEN A DECIMAL POINT" ON THE PATIENT'S METER. AS THE PATIENT WAS ALREADY AT THE "SURGERY" SHE WAS TESTED ON THE HOSPITAL'S METER; HOWEVER, DOES NOT RECALL READING. SHE WAS TREATED WITH A "SUGARY DRINK" AND SOME BISCUITS. SHE WAS THEN ADMITTED IN THE WARD FOR AN HOUR AND THEN DISCHARGED. PATIENT REFUSED TO ANSWER WHETHER SHE FELT BETTER AFTER BEING TREATED WITH FOOD AND BEVERAGE. THE PATIENT IS UNSURE WHETHER HER READINGS HAVE GONE AS LOW A 2; HOWEVER, HAS HAD FREQUENT SYMPTOMS OF HYPOGLYCEMIA PRIOR TO THE EVENT (SHE DOES NOT RECALL WHAT HER READINGS WERE WHEN SHE EXPERIENCED THE HYPOGLYCEMIA). THE PATIENT REFUSED TO ANSWER ANY FURTHER CLINICAL INFORMATION. SHE DID NOT TAKE ANY EXTRA INSULIN BASED ON THE METER READINGS AND TOOK FOLLOWED HER NORMAL DIABETES REGIMEN. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE READINGS THE PATIENT OBTAINED ON THE METER AT THE TIME OF THE EVENT, READINGS PRIOR TO THE EVENT, WHETHER THE PATIENT FELT BETTER AFTER BEING TREATED WITH FOOD/BEVERAGE, WHERE THE PATIENT OBTAINED THE METER AND HOW LONG THE PATIENT HAD BEEN USING METER. WITH FURTHER INVESTIGATION, IT HAS BEEN DISCOVERED THE DECIMAL POINT IN CERTAIN GLUCOSE READINGS MAY BE DIFFICULT TO READ, FOR EXAMPLE, THE TAIL END OF NUMBER "2" AND A DECIMAL POINT ARE ONLY SEPARATED BY A PIXEL WHICH CAN BECOME HAD TO READ AN INTERPRET. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SYMPTOMS THAT MAY REPRESENT HYPOGLYCEMIA AND MAY HAVE MISINTERPRETED THE METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R
    2