BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1163077 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02246
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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, A PT/LAYPERSON ALLEGED THAT HIS ONETOUCH ULTRA2 METER HAD PROMPTED ERROR 2 ON TWO DAYS EARLIER BETWEEN 6 AND 6:30 PM. THE MESSAGE REPORTEDLY OCCURRED WHEN A TEST STRIP WAS INSERTED. THE PT REPORTED FEELING SWEATY, WEAK AND SHAKY AFTER THE ALLEGED ISSUE BEGAN. THE CUSTOMER CARE ADVOCATE REPLACED THE TEST TRIPS. THE PT REPORTED THE FOLLOWING TO THIS SENIOR MEDICAL AFFAIRS SPECIALIST ON THE FOLLOWING MONTH. THE RESULTS ARE IN MG/DL, CORRECT UNIT OF MEASURE. WHILE AWAITING THE ARRIVAL OF A REPLACEMENT ONETOUCH ULTRA2 DUE TO ANOTHER ALLEGED ISSUE THAT THE PT REPORTED TO LIFESCAN IN THE MORNING ON TWO DAYS PRIOR TO ORIGINAL DATE, HE CONTINUED TO USE THE SUBJECT METER AS WELL AS BORROW A FRIEND'S METER SINCE HE TESTS UP TO SIX TIMES A DAY. THE PT SUCCESSFULLY TESTED AT 3:30 PM, OBTAINING "376" ON THE SUBJECT METER. HE INJECTED HIS 50 UNITS OF NOVALOG. AT 4:30 PM, THE PT ATE "A SNACK" CONSISTING OF A BOWL OF SOUP AND A SMALL SALAD. AROUND 6 PM, THE PT REPORTEDLY OBTAINED ER2 WHEN TESTING ON THE SUBJECT METER. HE WAS UNABLE TO OBTAIN AN ACTIONABLE RESULT AND NEITHER ATE DINNER NOR INJECTED INSULIN. THIRTY TO FORTY-FIVE MINS LATER WHEN HE "FELT LOW", THE PT ATE PEANUT BUTTER AND CRACKERS AND LAY DOWN. ONE HR AFTER EATING, THE PEANUT BUTTER WITH CRACKERS, THE PT REPORTEDLY BECAME NAUSEATED AND THREW UP. AGAIN HE REPORTEDLY OBTAINED ER2 ON THE SUBJECT METER. THE PT ELECTED TO INJECT 8 UNITS OF REGULAR INSULIN ON A SLIDING SCALE ALTHOUGH UNABLE TO OBTAIN A RESULT. STILL SWEATING AND NAUSEATED WITH LEG CRAMPS, THE PT ELECTED TO GO TO BED. THE PT IS NOW UNCERTAIN WHETHER HE WAS HYPER OR HYPOGLYCEMIC DURING THE DESCRIBED SYMPTOMS AND EVENT. THE PT REC'D NO MEDICAL INTERVENTION. THE NEXT MORNING, HIS BLOOD GLUCOSE ON HIS FRIEND'S METER WAS "127". BECAUSE THE PT HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ISSUE BEGAN (ALTHOUGH THE EXTRA INSULIN TAKEN AND VOMITING OCCURRED DID NOT ADVERSELY AFFECT THE PT), THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2857636

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening