BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1873019 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09152
    Event Type
    Injury
    Date Received
    October 18, 2010
    Report Date
    October 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE 510(K) # IS K082513.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. 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

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE CALIBRATOR DISPLAYED AN ERROR MESSAGE THAT READ "CALIBRATION SLOPE ERROR". AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® VITA METER IS GIVING INACCURATE HIGH READING OF 185 MG/DL COMPARED TO 128 MG/DL OBTAINED ON ANOTHER METER. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE PATIENT OBTAINED THE ALLEGED INACCURATE READING ONE MONTH PRIOR TO CONTACTING LFS. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY INCREASED HIS INSULIN DOSE TO 14 UNITS IN THE MORNING, 12-13 UNITS BEFORE LUNCH, AND 38 UNITS IN THE EVENING. SUBSEQUENTLY, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF SWEATY AND FEELING DISCOMFORT." THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION AT THE TIME OF CONCERN. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO PERFORM A QUALITY TEST. FURTHERMORE, THE PATIENT COMPARED HIS REPORTED LFS METER READINGS OF 185 AND 128 MG/D TO A CONTINUOUS GLUCOSE MONITORING DEVICE. NO NUMERIC VALUE FOR THE CONTINUOUS GLUCOSE MONITORING DEVICE WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD SYMPTOMS THAT CAN SUGGESTIVE OF HYPOGLYCEMIA AFTER HE INCREASED HIS INSULIN PER THE LFS METER READING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN OUT-OF-SERVICE FORM THAT THIS DEVICE AND LEAD SYSTEM WERE EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3047765

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening