BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5222236 · Received November 13, 2015

    Report

    Report Number
    2939301-2015-48749
    Event Type
    Injury
    Date Received
    November 13, 2015
    Report Date
    November 3, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DEVICE EVALUATION. THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA 2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT THE PATIENT NOTICED THAT SUBJECT METER WAS READING INACCURATELY ON (B)(6) 2015, WHEN HE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT WITH THE SUBJECT METER OF "60 MG/DL" COMPARED TO "40 MG/DL" ON A HOSPITAL METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE RESULTS FALLS WITHIN LFS' CRITERIA FOR ACCURACY. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF MEDICATIONS INCLUDING INSULIN. THE REPORTER CLAIMED THAT "SOMETIME IN (B)(6)", THE PATIENT HAD CONSUMED MORE FOOD/DRINK AFTER OBTAINING ALLEGED INACCURATE HIGH RESULTS AND HAD SUBSEQUENTLY DEVELOPED SYMPTOMS OF "SWEATING [AND] CONFUSION". THE REPORTER INDICATED THAT THE PATIENT HAD SELF-TREATED HIS SYMPTOMS WITH "MORE FOOD/DRINK". DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE PATIENT HAD USED AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753048 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3613157

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R