BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2801393 · Received October 23, 2012

    Report

    Report Number
    2939301-2012-12258
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K001109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    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

    (B)(4): THE METER WAS FOUND TO HAVE A DEFECTIVE BATTERY.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) 2012, A REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ON BEHALF OF THE PATIENT ALLEGING AN ERROR 2 MESSAGE ON THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT HAD NOT BEEN ABLE TO OBTAIN A BLOOD GLUCOSE RESULT IN 14 DAYS DUE TO THE ALLEGED ERROR 2 MESSAGE ON HIS ONE TOUCH ULTRA METER. THE REPORTER MENTIONED THAT THE PATIENT HAD COLLAPSED TWICE DUE TO NOT BEING ABLE TO TEST AND BEEN TAKEN TO THE ER. THE REPORTER MENTIONED THAT THE FIRST INCIDENT WAS ON (B)(6) 2012 AND THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR 3 DAYS AND THE SECOND TIME WAS (B)(6) 2012 AND THE PATIENT WAS ADMITTED FOR 10 DAYS. THE REPORTER DID NOT KNOW WHAT THE DIAGNOSIS WAS FOR EITHER OF THE HOSPITAL ADMISSION. THE REPORTER WOULD NOT PROVIDE ANY FURTHER INFORMATION ABOUT THE INCIDENT, TREATMENT THE PATIENT RECEIVED IN THE HOSPITAL OR BLOOD GLUCOSE READINGS IN THE HOSPITAL. REPORTER MENTIONED THAT WHEN THE METER HAD NOT BEEN WORKING THE PATIENT HAD CONTINUED TO TAKE HIS INSULIN. REPORTER MENTIONED THAT DURING ONE OF THE INCIDENTS, THE PATIENT HAD TAKEN HIS INSULIN AROUND LUNCH TIME AND RIGHT BEFORE EVENING HE FAINTED. REPORTER ONLY REMEMBER THAT WHEN SHE CAME TO HELP THE PATIENT SHE GAVE HIM A PIECE OF SUGAR SINCE HE WAS HAVING HYPOGLYCEMIC SYMPTOMS ( REPORTER DID NOT PROVIDE THE EXACT SYMPTOMS) AND THEN THE PATIENT COLLAPSED, WAS SHAKING AND HAD FOAM COMING OUT OF HIS MOUTH. SHE THEN CONTACTED THE PARAMEDICS. THE REPORTER MENTIONED THAT SHE THINKS THAT THE PATIENT'S TEST STRIPS HAD BEEN OPENED LONGER THAN SIX MONTHS. USING EXPIRED TEST STRIPS ON THE METER IT MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. REPORTER WAS UNWILLING TO TROUBLESHOOT ANY FURTHER WITH THE CUSTOMER SERVICE AGENT. PER THE OWNER'S BOOKLET AN ERROR 2 MESSAGE COULD BE CAUSED BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERROR 2 MESSAGE, THE PATIENT WAS UNABLE TO TEST, CONTINUED TO TAKE HIS INSULIN, DEVELOPED HYPOGLYCEMIC SYMPTOMS AND HAD TO BE ADMITTED IN THE HOSPITAL TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3316883

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R