BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1905123 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10212
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    November 9, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/08/2010. 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. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 1/05/2011: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL DISC REPLACEMENT. AN UNKNOWN TIME POST-OP, AN OSTEOPHYTE FORMED POSTERIOR TO THE IMPLANT. PER THE HEALTH CARE PROFESSIONAL, THE OSTEOPHYTE IS NOT RELATED TO THE DISC. THERE WAS NO IMPLANT/ BONE INTERFACE FAILURE. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY THREE YEARS POST-OP TO REMOVE THE ARTIFICIAL DISC AND FUSE THE LEVEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN ADMINISTRATION SET FOR BLOOD WHERE THERE WAS TURBULENCE IN THE CHAMBER WHEN THE ROLLER CLAMP IS FULLY OPEN CREATING LARGE AIR BUBBLES IN THE LINE WHICH ENTERED INTO THE PATIENT. A PATIENT WAS INVOLVED BUT NO INJURY WAS INCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELING/ NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS FOUR TIMES A DAY AND MANAGES HIS DIABETES WITH 15 UNITS OF NOVOLOG FOUR TIMES A DAY (BEFORE MEALS, WITHIN A 24 HOUR TIME PERIOD) AND BECAUSE THE PATIENT WORKS THE EVENING SHIFT, THE PATIENT STATED HE ADMINISTERS 50 UNITS OF LANTUS IN THE MORNING. THE PATIENT CONFIRMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 (IN THE MORNING). ON UNKNOWN DATES/TIMES, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "176, 171, 159, 139, 163, 225, 242, 175, 177, AND 241MG/DL" WITH THE SUBJECT METER. IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT CORRECTED AND CLARIFIED (BEGINNING (B)(6)), HE CONTINUED WITH HIS USUAL DOSE OF MEDICATIONS (PRIOR TO HIS MEAL); HOWEVER, THE PATIENT CLARIFIED HE CONSUMED LESS FOOD. ON AN UNKNOWN DATE/TIME, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF SWEATING, SHAKING, NERVOUSNESS, AND HUNGER. THE PATIENT RECALLED TESTING HIS BLOOD GLUCOSE AT THE ONSET OF HIS SYMPTOMS AND OBTAINED A RESULT OF "63 MG/DL" WITH THE SUBJECT METER (DATE/TIME UNKNOWN). IN RESPONSE TO HIS SYMPTOMS, THE PATIENT CLARIFIED HE CONSUMED FOOD AND FELT BETTER SOON AFTER; THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE AFTER TREATMENT. THE PATIENT CONFIRMED HE WAS ADVISED BY HIS PHYSICIAN (DURING A DOCTOR'S OFFICE VISIT) TO INCREASE HIS LANTUS INSULIN TO 53 UNITS; HOWEVER, THE PATIENT INDICATED HE DISREGARDED THE PHYSICIAN'S ADVICE AND CONTINUED WITH HIS USUAL 50 UNITS OF INSULIN. DURING TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3054223

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening