BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1387980 · Received May 18, 2009

    Report

    Report Number
    2939301-2009-02910
    Event Type
    Injury
    Date Received
    May 18, 2009
    Report Date
    May 4, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRAMINI METER HAD AN "ERROR 1" ISSUE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PT ON MAY 15, 2099, AND WAS ABLE TO OBTAIN/VERIFY INFO. THE PT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE TESTS BEFORE BREAKFAST AND DINNERTIME AROUND (7:00-8:00 PM). THE PT MANAGES HER DIABETES WITH SET DOSAGES OF HUMULIN 70/30 INSULIN TAKEN TWICE A DAY. SHE DOES NOT ADJUST HER INSULIN DOSAGES BASED ON HER METER READINGS. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON ORIGINAL DATE, AT AROUND 10:00 AM THAT DAY, THE PT DID NOT MAKE ANY CHANGES TO HER DIET OR MEDICATION DOSAGES. SHE ATE DINNER AS USUAL AND TOOK HER DINNERTIME DOSE OF INSULIN. AT 10:00 PM THAT EVENING, THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SWEATING, SEEING DOTS, AND FEELING HOT. THE PT FELT AS THOUGH HER BLOOD GLUCOSE WAS LOW SO SHE ADMINISTERED SELF-TREATMENT BY EATING CANDY. THE SELF-TREATMENT HELPED TO RELIEVE HER SYMPTOMS. THE PT INFORMED THE MSS THAT SHE WAS NOT SURE IF SHE COULD HAVE PREVENTED THE REPORTED SYMPTOMS FROM DEVELOPING. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2916390

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R