BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1923484 · Received December 13, 2010

    Report

    Report Number
    2939301-2010-10697
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 20, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/14/2010. 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 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 K061118.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THERE WAS DIFFICULTY CROSSING THE LESION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID RCA (RIGHT CORONARY ARTERY). PREDILATION WAS PERFORMED WITH A 2.0X15MM BALLOON TWO TIMES TO 14ATM. THE 2.5X32MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. A 2.5X18MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL PORTION OF THE LESION AND THE DISTAL PORTION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 10:00AM. THE PATIENT'S REPORTER REPORTED BLOOD GLUCOSE RESULTS OF "133 MG/DL" WITH THE SUBJECT METER AND "83 MG/DL" ON ANOTHER METER (EMERGENCY MEDICAL SERVICE METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT'S REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT'S REPORTER STATED THAT THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT REGIMEN. THE PATIENT'S REPORTER STATED 10-15 MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BECAME INCOHERENT ON THE FLOOR. AT THE SAME TIME OF THE ALLEGED ISSUE, THE PATIENT'S REPORTER CLAIMED EMERGENCY MEDICAL SERVICES (EMS) CAME AND TESTED HIM ON THE EMS METER WITH READINGS OF "83 AND 20 MG/DL", AND WAS TREATED WITH GLUCOSE TABLETS/GLUCOSE GEL. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE CODING WAS INCORRECT; HOWEVER WAS ABLE TO CONFIRM THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT. THE PATIENT WAS ABLE TO PERFORM A CONTROL SOLUTION TEST AND THE RESULT WAS WITHIN THE SPECIFIED CONTROL RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN ALLEGED INACCURATE HIGH READING THAT DID NOT CORRELATE WITH THE RECEIVED TREATMENT FROM THE EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3039306

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention