BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2861338 · Received December 7, 2012

    Report

    Report Number
    3008382007-2012-07357
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 6, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    (B)(4): THE METER HAS PASSED 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WOULD NOT POWER ON. THE SR MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. DURING THIS TIME PERIOD, THE PATIENT CONTINUED TO FOLLOW HER USUAL DIABETES MANAGEMENT ROUTINE, MANAGED WITH DIET AND EXERCISE. THE PATIENT REPORTED SHE WOULD GO SEVERAL DAYS WITHOUT EATING FOOD. ON (B)(6) 2012, THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA AND BLURRED VISION. THE PATIENT DID NOT SEEK ANY EMERGENCY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. IT WAS ALSO REVEALED THE PATIENT HAD NOT REPLACED THE METER'S BATTERY AS RECOMMENDED BY THE MANUFACTURER. THE ISSUE WAS NOT RESOLVED, AS THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT BY NOT REPLACING THE METER'S BATTERY. THERE WAS NO EVIDENCE THE METER WAS NOT FUNCTIONING APPROPRIATELY. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER THE METER POWER ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3312392

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening