BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1760362 · Received July 18, 2010

    Report

    Report Number
    2939301-2010-05736
    Event Type
    Injury
    Date Received
    July 18, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, THE JAWS ON DEVICE WERE DIFFICULT TO OPEN AND CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING A BATTERY INDICATOR ISSUE WITH A ONE TOUCH ULTRA 2 METER. THE PATIENT TESTS HER BLOOD GLUCOSE 3 TIMES A DAY. SHE TESTS BEFORE BREAKFAST, AND AFTER LUNCH AND DINNER. THE PATIENT REPORTED A METER READING OF "472 MG/DL." THE PATIENT MANAGES HER DIABETES WITH HUMULIN INSULIN TAKEN TWICE A DAY. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON AN UNSPECIFIED DATE/TIME A WEEK PRIOR TO CONTACTING LFS ON (B)(6) 2010. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE WITH THE REPORTED LFS METER OR ANY OTHER DEVICE. DURING THAT TIME, THE PATIENT DID NOT MODIFY HER INSULIN REGIMEN BUT ATE LESS DUE TO HAVING A COLD. ABOUT A WEEK AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF DIZZINESS, THIRSTINESS, BLURRED VISION, AND SLEEPINESS. THE PATIENT COULD NOT RECALL WHAT HER LAST METER READING WAS BEFORE THE ALLEGED ISSUE BEGAN. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. THROUGH TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DETERMINED THAT THE METER¿S BATTERY NEEDED TO BE REPLACED. THE PATIENT DID NOT HAVE A REPLACEMENT BATTERY FOR TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2947144

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening