BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4213922 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29040
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 20, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/21/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 12/5/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/9/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN IN SEPTEMBER 2014, EXACT DATE/TIME IS NOT KNOWN. THE PATIENT REPORTED OBTAINING VALUES OF ¿178,150,152,229, 296 MG/DL¿ WITH THE SUBJECT METER WHICH SHE FELT WERE HIGH AS COMPARED TO HER USUAL READINGS/FEELINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN AND IS A SELF-ADJUSTER. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNKNOWN TIME AFTER TESTING, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF ¿SHAKING¿ BUT DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION. QUALITY CONTROL TESTING PASSED. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER OBTAINING HIGH READINGS ON THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696952 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3681930

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening