BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1960477 · Received January 13, 2011

    Report

    Report Number
    2939301-2011-00474
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    January 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    SERIAL # OF METER (B)(4). A 510(K) # IS K001109. 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.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER SISTER'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT ON AN UNSPECIFIED DATE AND TIME IN (B)(6) 2010, SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A RESULT OF 36 MMOL/L. SHE DID NOT EXHIBIT ANY SYMPTOMS DUE TO THE ALLEGED HIGH READING. DUE TO THE ALLEGED HIGH READING, SHE INCREASED HER INSULIN ON HER OWN AND TOOK APPROXIMATELY 26-28 UNITS OF NOVORAPID INSULIN. SHE USUALLY TAKES 20 UNITS OF NOVORAPID INSULIN. SOON AFTER TAKING THE INSULIN, THE PATIENT DEVELOPED TINGLING IN HER LEGS, FELT SICK AND "SAW EVERYTHING LIGHTER THAN IT REALLY WAS". THE PATIENT TESTED HER BLOOD GLUCOSE WHEN EXHIBITING THE SYMPTOMS AND OBTAINED A 4.5 MMOL/L AND SELF-TREATED WITH JUICE. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. PATIENT MENTIONED SIMILAR INCIDENTS HAS HAD HAPPENED BEFORE AFTER TAKING AN INCREASE DOSAGE OF INSULIN DUE TO ALLEGED HIGH READINGS, SHE EXHIBITED SIMILAR SYMPTOMS AND HAD TESTED AND OBTAINED RESULTS OF 3.8 MMOL/L AND 2.9 MMOL/L. THE PATIENT SELF-TREATED HERSELF WITH JUICE AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN DUE TO THE ALLEGED ISSUE. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2011 DUE TO A COLD AND HER INITIAL READING IN THE HOSPITAL WAS 6.2 MMOL/L , A 2.6 BEFORE LUNCH AND A 6.2 AFTER LUNCH IN THE HOSPITAL. THERE IS NO INFORMATION ON WHETHER THE PATIENT ATTEMPTED TO TEST HER ON HER METER PRIOR TO GOING TO THE HOSPITAL. THE PATIENT WAS ADMITTED IN THE HOSPITAL ON (B)(6) AND WAS DISCHARGED ON (B)(6). WHILE HER STAY IN THE HOSPITAL, SHE WAS TREATED WITH AMOKSKLAV, SERETIDE AND INSULIN. THE PATIENT DOES NOT KNOW WHAT THE DIAGNOSIS WAS IN THE HOSPITAL. THE PATIENT CLAIMS HER DIABETES REGIMEN HAS NOT CHANGED. PATIENT WAS UNABLE/UNWILLING TO FURTHER TROUBLESHOOT THE DEVICE OR TO RUN A QUALITY CONTROL TEST ON THE METER. PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, SHE TOOK AN INCREASE DOSAGE OF INSULIN AND SHORTLY LATER DEVELOPED SYMPTOMS WHICH ARE NOT SUGGESTIVE OF A SERIOUS INJURY; HOWEVER, SHE HAD TO SELF-TREAT WITH JUICE FOR RESULTS BELOW THAN 65 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3042187

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R