BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2060377 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03141
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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 (05/23/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(6), 2011, RESPECTIVELY. TESTING WAS PERFORMED ON THE METER ON (B)(6), 2011 AND TESTING ON TEST STRIPS WERE DONE ON (B)(6), 2011. THE ALLEGED ISSUE WAS NOT CONFIRMED WITH DEVICE EVALUATION: TESTING DID NOT FIND ANY FAULTS WITH THE PRODUCTS. RETAIN TESTING WAS ALSO PERFORMED ON (B)(6), 2011 AND PASSED ALL TESTING. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(6) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA EASY METER. THE PATIENT MENTIONED THAT ON (B)(6) 2011, SHE WAS SHAKING. SHE TESTED HER BLOOD GLUCOSE AND OBTAINED AN 18.6 MMOL/L. SHE WAS CONFUSED BECAUSE SHE FELT HER READING SHOULD HAVE BEEN LOWER BASED ON HER SYMPTOMS. DUE TO THE METER READING SHE TOOK 4 EXTRA UNITS OF HER HUMALOG INSULIN. APPROXIMATELY 30 MINUTES LATER, HER SYMPTOMS PROGRESSIVELY GOT WORSE AND WHEN SHE TESTED HER BLOOD GLUCOSE HER READING WAS 4.0 MMOL/L AND THEN DROPPED TO 2.0 MMOL/L. THE PATIENT THEN SELF-TREATED HERSELF WITH A KIT KAT. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE SHE DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. ALTHOUGH THE PATIENT WAS ALREADY IN A SERIOUS INJURY PRIOR TO TESTING, SHE TOOK EXTRA INSULIN BASED ON THE ALLEGED METER RESULT AND LATER SYMPTOMS GOT WORSE AND HAD TO SELF-TREAT WITH FOOD TO ELEVATE HER BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068727

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening| R