BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1831543 · Received September 10, 2010

    Report

    Report Number
    2939301-2010-07782
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.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 ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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.

    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

    THE FEMALE CONNECTOR OF THE TRANSFER SET GOT A CRACK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "NO PHACO" (NO CODE AVAILABLE). THE NURSE REPORTED THERE WAS NO PHACO DURING SURGERY. THE HANDPIECE AND TIP WERE SWITCHED OUT AND THE CASE WAS COMPLETED AS PLANNED. THE NURSE STATED SHE WAS UNSURE IF THE ISSUE WAS WITH THE HANDPIECE, TIP, OR SYSTEM. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2010, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2010 AT 6:30 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 167 MG/DL ON THE REPORTED METER, AND A LABORATORY READING OF 126 MG/DL WITHIN 10 MINUTES. THE PATIENT DID NOT TAKE ANY ACTION BASED ON THIS METER READING. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE LEVEL USING THE REPORTED METER WHILE HE WAS SYMPTOMATIC. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING SUGAR; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT WAS UNWILLING TO PROVIDE HIS INSULIN REGIMEN, EXPECTED BLOOD GLUCOSE READINGS AND IF THESE WERE FASTING BLOOD GLUCOSE RESULTS. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE OBTAINED AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE THOSE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3024794

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening