BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1963115 · Received January 18, 2011

    Report

    Report Number
    2939301-2011-00534
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/21/11)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER, RETURNED TEST STRIPS, AND RETAIN TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS METER AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED. 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 USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THE ON (B)(6) 2011, THE PATIENT HAD TESTED AND OBTAINED A 30 MMOL/L. THE PATIENT TOOK AN INCREASE OF INSULIN AND TOOK 20 UNITS. THE PATIENT TOOK INSULIN ON HIS OWN AND NOT BASED ON THE PHYSICIAN'S RECOMMENDATION. APPROXIMATELY 2 HOURS LATER, THE PATIENT FELT SWEATY AND DIZZY. THE PATIENT DID NOT ATTEMPT TO RETEST; HOWEVER, TREATED HIMSELF WITH SUGAR AND FELT BETTER RIGHT AWAY. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. A NORMAL READING FOR THE PATIENT IS 9-10 MMOL/L. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS DONE AND THE TEST STRIPS FAILED USING THE CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, HE TOOK AN INCREASE DOSAGE OF INSULIN ON HIS OWN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3034785

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R