BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3971996 · Received July 31, 2014

    Report

    Report Number
    2939301-2014-19272
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 25, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/15/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 9/2/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/3/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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/REPORTER CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRA2 METER HAD REVERTED TO THE SETUP MODE IMMEDIATELY FOLLOWING A BATTERY REPLACEMENT. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 7:30 AM THE PATIENT NOTED THE REPORTED METER REVERTED TO THE SETUP MODE AFTER SHE REPLACED THE BATTERY; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ACCORDING TO THE OWNER¿S BOOKLET, THIS METER MAY DISPLAY THE SETUP MODE AFTER THE BATTERY IS REPLACED TO ALLOW THE USER TO UPDATE THE SETTINGS. THE PATIENT FOLLOWED HER USUAL DIABETES ROUTINE AFTER THE USE OF THE METER. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF BEING DISTRAUGHT AND SHAKING AFTERWARDS; SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND PATIENT EDUCATION. THERE WAS NO EVIDENCE THE METER WAS NOT FUNCTIONING APPROPRIATELY. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE OCCURRED, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447229 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3632057

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening