BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1834301 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07923
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 510K K021819.

    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. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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 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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRASMART METER IS GIVING INACCURATE HIGH READING OF "199 MG/DL" COMPARED TO THE HA1C. THE PATIENT'S DIABETES IS MANAGED WITH INSULIN- NO SLIDING SCALE REGIMEN. THE ELEVATED READINGS BEGAN ONE MONTH PRIOR TO CONTACTING LIFESCAN. AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT REPORTEDLY DESCRIBED SYMPTOMS DESCRIBED AS 'DIZZY SPELLS" TWO WEEKS LATER. ON THE MORNING OF (B)(6) 2010, THE PATIENT WENT FOR A DOCTOR'S OFFICE VISIT WHERE HE WAS TESTED ON THE DOCTOR'S METER AT "64 MG/DL" AND CLAIMED HIS HEALTHCARE PROVIDER TREATED HIM WITH FOOD/DRINK AT THE TIME OF CONCERN. IT IS NOT CLEAR IF THE PATIENT WAS FASTING AT THE TIME OF CONCERN FOR LAB BLOOD WORK AND WHAT READINGS HE OBTAINED ON THE SUBJECT METER PRIOR TO AND DURING THE DOCTOR'S OFFICE VISIT. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE PATIENT WAS UNABLE TO PROVIDE ANY RESULTS FOR THE CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION SUGGESTIVE FOR HYPOGLYCEMIA AFTER THE PRODUCT ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 23008. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE TURNED OFF THE SYSTEM AND BACK DROVE THE AFFECTED MASTER TOOL MANIPULATOR TWO TIMES, HOWEVER, UPON RESTARTING THE SYSTEM, THE FAULT RECURRED. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2999794

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention