BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SS ENHANCED METER

    MDR report key: 1869967 · Received October 14, 2010

    Report

    Report Number
    2939301-2010-09052
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    October 2, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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; 510(K) # IS K022724.

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 11/19/2010: 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 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

    A PEDIATRIC PATIENT (IN PATIENT) RECEIVED A 2ND DEGREE BURN FROM A HEAT LAMP. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DEVICE WAS PLACED TOO CLOSE TO THE PATIENT (MORE THAN 28 CM PER MANUFACTURER RECOMMENDATIONS)

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH SURESTEP ENHANCED METER WAS GIVING INACCURATELY LOW READINGS COMPARED TO HER EXPECTED VALUES AND TO ANOTHER METER. ON (B)(6), 2010 THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON AN UNSPECIFIED DATE AT 10:00 AM, THE PATIENT OBTAINED A FASTING BLOOD GLUCOSE READING OF "IN THE 130'S" MG/DL ON THE REPORTED METER, WHICH WAS LOW COMPARED TO HER EXPECTED VALUES OF BETWEEN 160 MG/DL AND 180 MG/DL. IMMEDIATELY AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. THE PATIENT ADMINISTERED SELF-TREATMENT WITH ORANGE JUICE AND FELT BETTER AFTERWARDS; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT ALSO REPORTED THE FASTING METER READINGS OF 134 MG/DL ON (B)(6), 2010, 133 MG/DL ON (B)(6), 2010 AND 163 MG/DL ON (B)(6), 2010. THE PATIENT CLAIMED THAT THESE RESULTS WERE LOW COMPARED TO RESULTS OBTAINED USING ANOTHER METER AT THE SAME TIME; HOWEVER SHE WAS UNABLE TO PROVIDE ANY SPECIFIC RESULTS. THE PATIENT TAKES THE ORAL DIABETES MEDICATIONS METFORMIN AND GLYBURIDE TWICE PER DAY. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT, WHICH CAN CAUSE INACCURATE READINGS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED READINGS USING THE REPORTED METER, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE THOSE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY AFTER THE IMPLANTATION OF ONE 2.5 X 28 XIENCE V STENT IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE 2.5 X 23 XIENCE V STENT IN THE MID LAD, THE PATIENT EXPERIENCED ANGINA, WAS FOUND TO HAVE ELEVATED CK-MB, AND WAS DIAGNOSED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION THAT WAS TREATED WITH NITROGLYCERIN. THE PATIENT'S CONDITION RESOLVED WITHOUT SEQUELA TWO DAYS POST PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SS ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2939074004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening