BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3010099 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05561
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIP 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. DEVICE RETURNED TO MFG DATE: METER- 3/25/2013, TEST STRIPS- 3/27/2013.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE 2X DAILY AND MANAGES HIS DIABETES WITH INSULIN (25 UNITS 2X DAILY). THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "160-170 MG/DL" WITH THE SUBJECT METER. THAT EVENING, THE PATIENT ADMINISTERED SELF AN INCREASED DOSE OF INSULIN PER HIS PHYSICIAN'S ADVICE (TOTAL 24 UNITS). ABOUT 6AM THE FOLLOWING MORNING, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "135 MG/DL;" HOWEVER, HIS USUAL RESULT IS AROUND "100 MG/DL." IT IS NOT KNOWN IF THE PATIENT MADE ANY ADDITIONAL CHANGES TO HIS USUAL MANAGEMENT ROUTINE. BY 10AM, THE PATIENT CLAIMS HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SHAKY KNEES AND DIZZY. THE PATIENT TOOK DEXTROSE ENERGY TABLETS AND REPORTEDLY FELT BETTER AROUND LUNCHTIME. THE PATIENT RETESTED AND OBTAINED A BLOOD GLUCOSE RESULT OF "83 MG/DL" WITH THE SUBJECT METER. THE PATIENT DENIED TESTING WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113822 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R