BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1820474 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07368
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 17, 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 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.

    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.510(K) # IS K053529.

    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

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE BLADE WAS BROKEN. NO PIECE FELL INTO THE PATIENT. THE SURGEON OPENED A SECOND DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. A V18 .018 GUIDE WIRE AND ANOTHER MANUFACTURER'S 6FR MULTIPURPOSE GUIDE CATHETER WAS SELECTED. A 5.0X19X90CM EXPRESS SD BILIARY STENT DELIVERY SYSTEM WAS ADVANCED THROUGH THE GUIDE CATHETER BUT WOULD NOT CROSS THE LESION. DURING AN ATTEMPT TO PULL BACK THE STENT DELIVERY SYSTEM, THE GUIDE CATHETER TIP WAS DEFORMED NOT ALLOWING THE STENT DELIVERY SYSTEM TO BE PULLED BACK. THE FORCE OF PULLING BACK THE STENT DELIVERY SYSTEM PUSHED THE STENT OFF THE BALLOON WHILE STILL ON THE GUIDE WIRE. ANOTHER MANUFACTURER'S SNARE WAS INTRODUCED AND ADVANCED OVER THE GUIDE WIRE. THE STENT WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH THE BALLOON ONLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH ULTRA 2 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 1:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 87 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH. AT 1:30 AM THE PATIENT TOOK NPH INSULIN 22 UNITS AND LANTUS INSULIN 10 UNITS. THE PATIENT'S USUAL BLOOD GLUCOSE READINGS AT THAT TIME OF NIGHT RANGE FROM 70 MG/DL TO 110 MG/DL. THE PATIENT'S INSULIN REGIMEN DICTATES HE IS TO TAKE 22 UNITS NPH INSULIN BASED ON A METER READING WITHIN THIS RANGE. THE PATIENT DID NOT EAT ANYTHING AFTER TAKING THIS INSULIN DOSE. AT 5:00 AM THE PATIENT EXPERIENCED THE SYMPTOM OF CONVULSIONS. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE LEVEL USING THE REPORTED METER WHILE HE WAS SYMPTOMATIC, AND DID NOT RECEIVE ANY SELF-TREATMENT. THE PATIENT'S DAUGHTER CONTACTED EMERGENCY SERVICES. PARAMEDICS ARRIVED AT 6:00 AM AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 39 MG/DL. THE TSR CONFIRMED THE PATIENT DID RECEIVE TREATMENT, AND WAS TREATED INTRAVENOUSLY WITH GLUCOSE. HE WAS NOT TRANSPORTED TO THE EMERGENCY ROOM. ON (B)(6) 2010, THE DAY PRIOR TO THIS EVENT, THE PATIENT CONSUMED LESS FOOD, AND TOOK HIS USUAL DOSES OF INSULIN AT 7:00 PM. THE PATIENT WAS UNABLE TO PROVIDE HIS METER READINGS FROM THAT DAY. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A BLOOD GLUCOSE READING TAKEN ON THE REPORTED METER, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R