BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2312614 · Received October 28, 2011

    Report

    Report Number
    2939301-2011-10691
    Event Type
    Injury
    Date Received
    October 28, 2011
    Report Date
    October 7, 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 K053529. ANOTHER LOT # OF TEST STRIPS IS 2888224. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. LFS RECEIVED THE TEST STRIPS LOT # 3162741 AND THE TEST STRIPS PASSED TESTING . THE METER WAS RETURNED AND THE METER PASSED TESTING. IF THE OTHER TEST STRIPS 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 ((B)(4) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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 LIFESCAN (LFS) ALLEGING INACCURATE LOW READINGS ON HIS ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT SINCE THE PATIENT DID NOT PROVIDE A PHONE NUMBER THE FOLLOWING IS BASED ON THE INITIAL CALL. THE PATIENT MENTIONED THAT HE HAS BEEN OBTAINING ALLEGED LOW READINGS SINCE (B)(6) 2011. ON A FEW OCCASIONS HE MENTIONED HE HAD "HYPO" SYMPTOMS AT 2:00AM IN THE MORNING OF FREQUENT URINATION. THIS OCCURRED ON (B)(6) 2011. IT IS UNKNOWN WHAT HIS READINGS WERE PRIOR TO THE INCIDENT OR WHETHER HE ATTEMPTED TO TEST AT THE TIME OF THE SYMPTOMS. LATER DURING THE DAY HE MENTIONED HE HAD OBTAINED RESULTS IN THE 3-4'S MMOL/L. IT IS ALSO UNKNOWN WHAT HE SELF-TREATED WITH AND HOW SOON AFTER HE FELT BETTER. ON (B)(6) 2011 HE HAD OBTAINED READINGS IN THE 6-7'S MMOL/L HOWEVER FELT TIRED AND LOUSY. HE THEN WOULD EAT A BANANA TO ELEVATE HIS READINGS. THE PATIENT MENTIONED THAT HE HAD OBTAINED A RESULT IN THE 6-7'S MMOL/L, ON (B)(6) 2011 AT AROUND 2:00AM. THESE READINGS ARE NORMAL READINGS FOR HIM . DUE TO THE ALLEGED ISSUE, THE PATIENT DID NOT TAKE ANY ACTION; HOWEVER, AT AN UNSPECIFIED TIME LATER, THE PATIENT FELT SHAKY, AND FELT SICK. THE PATIENT DID NOT ATTEMPT TO TEST; HOWEVER, SELF-TREATED BY EATING A BANANA . PATIENT FELT THAT HIS NEW INSULIN HE WAS GIVEN MAY BE THE PROBLEM SINCE EVERY SINCE HE STARTED TAKING THE NEW INSULIN, HE HAS NOT BEEN FEELING WELL. WHEN HE MENTIONED THIS TO HIS PHYSICIAN THE PHYSICIAN ADVISED HIM TO CHECK HIS METER USING THE CONTROL SOLUTION. THE TEST STRIPS THE PATIENT HAD BEEN USING AT THE TIME WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED DUE TO THE ALLEGED INACCURATE LOW READING, HE LATER DEVELOPED SYMPTOMS OF FREQUENT URINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3162741

    Patients

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