BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 4183432 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27949
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT INDICATED THAT HE FIRST NOTICED THE SUBJECT METER WAS READING INACCURATELY HIGH DURING THE EVENING OF (B)(6) 2014, AND HE ALLEGED THAT FOR THE NEXT 3 DAYS HIS BLOOD GLUCOSE RESULTS WERE HIGHER THAN USUAL. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER). HE REPORTED, DATE/TIME UNKNOWN, OBTAINING AN ALLEGED BLOOD GLUCOSE RESULT OF 315 MG/DL WITH THE SUBJECT METER. HE REPORTED, DATE/TIME UNKNOWN, INCREASING HIS INSULIN DOSE (10UNITS). HE ALLEGED THAT AS A RESULT OF THE INCREASED DOSE OF INSULIN, ON OCTOBER 16 AT 2:30PM, HE DEVELOPED SYMPTOMS OF ¿DIZZY AND SWEATING¿. TREATMENT FOR THE PATIENT¿S SYMPTOMS WAS NOT SPECIFIED. DURING TROUBLESHOOTING, THE CSR ESTABLISHED THAT THE PATIENT¿S METER HAD BEEN SET TO THE CORRECT UNIT OF MEASURE AND HIS TEST STRIPS HAD BEEN STORED CORRECTLY. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE WITH WHICH TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATELY HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664101 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3641173

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening