BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1092283 · Received August 1, 2008

    Report

    Report Number
    2939301-2008-01650
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE LAY USER/PT CONTACTED LIFESCAN ON (B)(6) 2008 AND ALLEGED THAT HIS ONE TOUCH ULTRA MINI METER WAS DISPLAYING THE ERROR 1 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED THE PT ON AUGUST 1, 2008 AND SPOKE WITH HIS WIFE WHO PROVIDED SOME ADD'L INFO. THE PT HAD REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON B)(6) 2008 (TIME NOT PROVIDED). HIS WIFE INFORMED THE MAS THAT HE HAD NOT TESTED HIS BLOOD GLUCOSE SINCE THAT DAY, SINCE THE METER KEPT GIVING HIM THE ERROR 1 MESSAGE. DURING THAT TIME, HE REPORTEDLY HAD CONTINUED TO TAKE HIS SET AMOUNT OF NOVALOG AND LANTUS INSULIN (DOSAGE NOT PROVIDED). THE WIFE DENIED THAT THE PT IS ON A SLIDING SCALE REGIMEN WITH THE NOVALOG INSULIN AND SINCE HE WAS NOT ABLE TO OBTAIN RESULTS ON THE METER, HE WOULD NOT HAVE TAKEN ANY EXTRA INSULIN EVEN IF HE WERE ON A SLIDING SCALE. THE PT HAD ALSO REPORTED THAT HE EXPERIENCED HEADACHES AND SHAKES AFTER THE REPORTED ISSUE BEGAN. THE WIFE MENTIONED THAT THE SYMPTOMS BEGAN ON B)(6) 2008 IN MID-MORNING. THE PT HAD HIS NORMAL BREAKFAST EARLY THAT MORNING AND HAD ALSO TAKEN HIS INSULIN. PER THE WIFE, HE ATE A CANDY AND FELT BETTER AFTER A WHILE. HE WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT WAS NOT ABLE TO TEST ON THE METER FOR A FEW DAYS DUE TO THE METER AND DURING THAT TIME, HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. HE TREATED HIMSELF WITH CANDY. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2750139

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R