BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1082198 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01505
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    July 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA METER WAS READING INACCURATELY. THE MEDICAL AFFAIRS SPECIALIST SPOKE TO THE PT TO OBTAIN/CLARIFY INFO. ABOUT ONE AND A HALF MONTHS AGO ABOUT 3-4 PM, THE PT HAD SEIZURES AND NEEDED TO BE ADMITTED TO THE HOSPITAL. THE DAY THE PT HAD SEIZURES, SHE REPORTEDLY OBTAINED A 158 MG/DL READING IN THE MORNING AND A 98 MG/DL READING AT NOON ON THE SUBJECT METER. THE PT DID NOT MENTION ANY INTERVENTION BASED ON THESE READINGS. THE PT IS ON A SET DOSE OF MEDICATION BUT SHE DID NOT SAY WHAT HER DOSES WERE. SHE TAKES GLYBURIDE AND INSULIN BUT DOES NOT KNOW THE NAME OF HER INSULIN. SHE WENT TO SLEEP AT AROUND NOON AND REPORTEDLY HAD SEIZURES LATER THAT AFTERNOON. HER MEMORY OF THAT DAY WAS NOT CLEAR AND SHE DID NOT KNOW WHAT SHE DID THAT DAY. SHE DID MENTION SHE TOOK A HIGHER DOSE OF HER MEDICATION THAT DAY. HER CAREGIVER CALLED THE AMBULANCE WHEN SHE HAD SEIZURES AND THEY OBTAINED A READING OF 13 MG/DL ON THEIR METER. WHILE SHE WAS ON HER WAY TO THE HOSPITAL, THE AMBULANCE GAVE HER SOMETHING TO DRINK. SHE WAS ADMITTED TO THE HOSPITAL LATER THAT DAY AND STAYED FOR A MONTH AND A HALF BECAUSE THEY ALSO FOUND A PROBLEM WITH HER HEART AND FOUND THAT SHE HAD KIDNEY FAILURE. THE PT TESTS HER BLOOD SUGAR 4-7 TIMES PER DAY. SHE SAYS SHE HAS NEVER HAD SEIZURES BEFORE. THE PT WAS NOT ABLE TO GIVE ANY ADD'L INFO. DURING THE TROUBLESHOOTING TELEPHONE CALL IT WAS DETERMINED THAT THE PT'S TESTING TECHNIQUE WAS CORRECT BUT THE PUNCTURE AREA WAS CLEANED INCORRECTLY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ALTHOUGH THE PT COULD NOT GIVE DETAILS OF HER TREATMENT ON THE DAY OF CONCERN, SHE ALLEGED SHE HAD INACCURATE READINGS ON THE SUBJECT METER AND LATER OBTAINED A READING BELOW 40 MG/DL ON THE AMBULANCE'S METER THAT NECESSITATED TREATMENT TO RAISE HER BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2680779

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R