BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1894564 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09766
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 510K #K061118.

    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 ULTRAMINI METER IS GIVING INACCURATE HIGH READING OF "549 MG/DL" COMPARED ANOTHER DEVICE METER READING OF "189 MG/DL." THE PATIENT MANAGES HIS DIABETES WITH SELF ADJUSTING INSULIN BASED ON THE LFS METER READINGS. ON (B)(6) 2010 AT 3 AM, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "31 MG/DL" ON THE HOSPITAL METER. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT BLOOD GLUCOSE READING THE PATIENT OBTAINED ON THE SUBJECT METER PRIOR TO AND DURING THE REPORTED HOSPITAL METER READING. LATER THAT DAY, AT 6 PM, THE PATIENT TESTED ON THE SUBJECT METER AT "549 MG/DL" WHILE OBTAINING A BLOOD GLUCOSE READING OF "189 MG/DL" ON ANOTHER DEVICE. AS A RESULT OF THE ALLEGED "549 MG/DL," THE PATIENT INCREASED HIS HUMALOG INSULIN TO 60 UNITS AND LEVIMIR INSULIN TO 20 UNITS. A FEW HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "DISORIENTATED, CONFUSED, AND ANXIOUS." THE PATIENT CLAIMED HE SUBSEQUENTLY RECEIVED MEDICAL INTERVENTION WITH IV GLUCOSE FROM HEALTHCARE PROVIDER DUE TO THE ALLEGED ELEVATED READING. 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 REPORTED METER READINGS OF "549 AND 189 MG/D" WERE TAKEN 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION SUGGESTIVE FOR HYPOGLYCEMIA AFTER HE INCREASED HIS INSULIN REGIMEN BASED THE ALLEGED INACCURATE HIGH READING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE JAWS STUCK TOGETHER WHEN FIRED AFTER THE INITIAL FIRING ON THE CYSTIC DUCT. THE DEVICE WAS REMOVED MANUALLY AND THE CASE WAS COMPLETED WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3060764

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R