BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060350 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01058
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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

    THE MEDICAL AFFAIRS SPECIALIST MADE A F/U CALL TO THE PT ON JUNE 10, 2008 TO OBTAIN/VERIFY THE FOLLOWING INFO. AT APPROXIMATELY TWO WEEKS PRIOR, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE LEVELS WITH HER ONETOUCH ULTRA METER BECAUSE THE METER KEPT ON SHOWING HER PAST READINGS. SHE ALSO INDICATED THAT SOMETIMES THE DISPLAY WAS BLANK AFTER INSERTING THE TEST STRIP. THE PT STATED THAT THE REPORTED ISSUE FIRST OCCURRED BETWEEN 3-4 PM (1 DAY BEFORE CONTACTING LFS) AND DOES NOT HAVE A BACKUP METER. THE PT'S LAST SUCCESSFUL METER TEST RESULT WAS REPORTEDLY OBTAINED IN THE MORNING ON THE EVENT DATE; HOWEVER, THE PT WAS UNABLE TO RECALL WHAT HER RESULT WAS. THE PT HAS HAD THE METER FOR 3-4 YRS AND TESTS BEFORE MEALS (3 TIMES PER DAY). SHE ALSO MANAGES HER DIABETES WITH ORAL MEDICATION (SET DAILY DOSAGES OF GLIPIZIDE AND METFORMIN). THE MORNING AFTER THE REPORTED ISSUES BEGAN (THE NEXT DAY AFTER BREAKFAST), THE PT REPORTEDLY BECAME SWEATY AND CLAMMY. SHE RECALLED EATING HER USUAL BREAKFAST THAT MORNING AND TAKING HER USUAL DOSE OF MEDICATIONS. SHE DID NOT KNOW IF IT WAS LOW OR HIGH BLOOD GLUCOSE LEVELS THAT WERE CONTRIBUTING TO HER SYMPTOMS BUT SHE OPTED TO EAT A CANDY BAR TO TREAT LOW BLOOD GLUCOSE, WHICH DID HELP ALLEVIATE HER SYMPTOMS. THE PT DID NOT RECEIVE ANY OTHER MEDICAL INTERVENTION OTHER THAN ADMINISTERING SELF-TREATMENT. THE PT NO LONGER HAD THE TEST STRIPS THAT SHE USED AT THE TIME; HOWEVER, WHEN THE PT RETESTED WITH A NEW VIAL OF TEST STRIPS, THE PT WAS ABLE TO OBTAIN SUCCESSFUL METER READINGS. THE CUSTOMER CARE ADVOCATE NOTED THAT THE ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODS WERE SENT TO THE PT. ALTHOUGH THE REPORTED ISSUES WERE RESOLVED WITH TRAINING, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUES BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R