BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3181621 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17977
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 31, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO RETURNED ON (B)(4) 2013, HOWEVER, EVALUATION HAS NOT YET BEEN COMPLETED. THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/08/2013) THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT. IT WAS NOTED A DEVIATION WAS IMPLEMENTED TO FULFILL NEW AIRLINE TRANSPORTATION REQUIREMENT. A ¿CAUTION¿ LABEL WAS APPLIED TO EACH SHIPPER BOX CONTAINING PRODUCTS WITH LITHIUM BATTERIES. THE DEVIATION DOES NOT HAVE ANY EFFECT ON THE FUNCTIONALITY OF THE PRODUCT OR RELATIONS TO THE REPORTED ISSUE. NO NON-CONFORMANCES OR REWORKS WERE OBSERVED. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 2 WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT ULTRA2 OWNER¿S MANUAL, AN ERROR 2 COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 6PM. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING METFORMIN AND GLIPIZIDE. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 22 HOURS AFTER THE ALLEGED ISSUE OCCURRED SHE ¿PASSED OUT.¿ THE PATIENT REPORTED ON (B)(6) 2013, AT 4:15PM, EMERGENCY MEDICAL SERVICES (EMS) ARRIVED. THE PATIENT REPORTED BETWEEN 4:30-4:45PM A READING OF ¿57-61MG/DL¿ WAS OBTAINED ON THE EMS METER AND THE PATIENT WAS GIVEN ¿SUGAR WATER¿ TO INCREASE HER BLOOD GLUCOSE TO ¿90MG/DL¿. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE SUBJECT TEST STRIPS WERE NOT AVAILABLE FOR TESTING. THE CCA DETERMINED THE INCORRECT TEST STRIPS WERE BEING USED. WHEN THE POWER BUTTON WAS PRESSED AN ERROR 2 DID NOT OCCUR. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND TOOK HER USUAL MEDICATIONS AND THEREFORE DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282011 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3439168

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R