BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1023250 · Received March 31, 2008

    Report

    Report Number
    2939301-2008-00424
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 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
    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

    IN 2008, THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT SAID THE PRODUCT ISSUE FIRST OCCURRED ON THE SAME DAY AT 8:00 AM. HE OBTAINED RESULTS OF 8.4 AND 17.2 MMOL/L ON THE REPORTED METER. HIS USUAL MORNING READING OF AROUND 10 MMOL/L. THE PATIENT DENIED HAVING SYMPTOMS OF HYPERGLYCEMIA AT THE TIME HE RECEIVED THE ABOVE READINGS. HE ALSO TESTED WITH HIS BACKUP METER AND OBTAINED A RESULT OF 17.7 MMOL/L, WHICH CORRELATED WITH THE READINGS ON THE REPORTED METER. THE PATIENT SAID HE TOOK HIS UNSPECIFIED HEART MEDICATION FIRST, BEFORE TAKING INSULIN, WHICH WAS DIFFERENT THAN HIS USUAL REGIMEN. HE SAID HE TOOK 28 UNITS OF RAPID INSULIN AND 38 UNITS OF NPH INSULIN BEFORE BREAKFAST IN RESPONSE TO THE METER READINGS. HE SAID HE IMMEDIATELY HAD BLURRY VISION AND FELT LIGHT HEADED, WHICH HE DESCRIBED AS SYMPTOMS OF LOW SUGAR. HE ATE BREAKFAST AND AFTERWARD FELT BETTER. HE DID NOT RETEST HIS BLOOD GLUCOSE LEVEL AFTER THE EVENT. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. THE CSR NOTED THAT A CONTROL SOLUTION TEST WAS IN RANGE; THE CONTROL SOLUTION OF 7.0 MMOL/L WAS WITHIN SPECIFICATIONS (5.7-7.7 MMOL/L). THE PATIENT'S PRODUCTS WERE REPLACED. THIS COMPLAINT IS REPORTED BECAUSE THE ALLEGES THAT HE TOOK INSULIN BASED ON AN INACCURATELY HIGH READING ON THE LFS PRODUCT BEFORE BREAKFAST AND IMMEDIATELY FELT LIGHT HEADED AND HAD BLURRY VISION. HE CLAIMS HE FELT BETTER AFTER EATING BREAKFAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2750098

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening