BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1051861 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00850
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    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, TEST STRIPS, AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER, STRIPS AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PT TWELVE DAYS LATER, AND OBTAINED/VERIFIED INFO. THE PT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE TESTS BEFORE BREAKFAST AND DINNERTIME. HER NORMAL PRE-BREAKFAST BLOOD GLUCOSE LEVELS ARE AROUND "100 SOMETHING" MG/DL. HER TYPICAL PRE-DINNER LEVELS ARE AROUND "220 MG/DL". THE PT TAKES HUMULIN-N INSULIN ON A SLIDING-SCALE BASED ON HER METER READINGS. SHE ALSO TAKES GLUCOPHAGE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE/TIME DURING THE LAST 2 WEEKS OF 2008. THE PT SAID THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR AROUND 2 WEEKS BECAUSE OF THE REPORTED ISSUE. ALTHOUGH THE PT WAS UNABLE TO USE THE REPORTED METER, SHE TOOK HER GLUCOPHAGE MEDICATION AS PRESCRIBED. THE PT ALSO TOOK HER USUAL/AVERAGE DOSES OF HUMULIN-N INSULIN. THE PATIENT SAID THAT SHE WAS PRETTY MUCH JUST GUESSING ON HOW MUCH INSULIN TO TAKE. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS OF FREQUENT URINATION. THE PT DENIED SEEKING OR RECEIVING MEDICAL ATTENTION AS A RESULT OF THE REPORTED METER ISSUE. HER BLOOD GLUCOSE WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. WHILE SPEAKING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE PT WAS ABLE TO TURN THE METER ON WITHOUT ANY ISSUES. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR ABOUT 2 WEEKS BECAUSE OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2701357

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening