BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2770146 · Received October 3, 2012

    Report

    Report Number
    2939301-2012-11370
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/03/2012 - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON [(B)(4) 2012] WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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 THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW. THROUGH INVESTIGATION OF THE COMPLAINT THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DETERMINED THAT THE ALLEGATION SHOULD HAVE BEEN CAPTURED AS THE SUBJECT METER ALLEGEDLY READING INACCURATELY HIGH. THE MSS WAS UNABLE TO REACH THE PATIENT FOR FOLLOW UP QUESTIONS AND SO THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). IT IS NOT CLEAR WHEN THE PATIENT FEELS THAT THE ALLEGED ISSUE BEGAN. THE PATIENT TOLD THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. THE PATIENT CLAIMED THAT AT 4 P.M. ON (B)(6) 2012 HE OBTAINED A BLOOD GLUCOSE RESULT OF '315 MG/DL' AND 2 MINUTES LATER A BLOOD GLUCOSE RESULT OF '585 MG/DL' WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. IT IS NOT CLEAR IF THE PATIENT MADE ANY CHANGES TO HIS NORMAL DIABETES MANAGEMENT OR ADMINISTERED TREATMENT AT THE TIME THAT THE REPORTED BLOOD GLUCOSE RESULTS WERE OBTAINED. THE PATIENT INFORMED THE CCA THAT AT 6 P.M. ON (B)(6) 2012 HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A BLOOD GLUCOSE RESULT OF '66 MG/DL.' THE PATIENT CLAIMED THAT HE WAS IN 'INSULIN SHOCK' AT THE TIME THE '66 MG/DL' RESULT WAS OBTAINED, BUT DENIED HAVING SYMPTOMS LEADING UP TO THE 'INSULIN SHOCK.' THE PATIENT MENTIONED THAT HE WAS FOUND IN HIS BACKYARD BY EMERGENCY MEDICAL SERVICES (EMS) AT THE TIME THE '66 MG/DL' RESULT WAS OBTAINED. THE PATIENT STATED THAT EMS TESTED HIS BLOOD GLUCOSE ON THEIR METER (UNSPECIFIED TYPE), OBTAINED A BLOOD GLUCOSE RESULT OF '25 MG/DL,' AND IMMEDIATELY TREATED HIM WITH INTRAVENOUS (IV) GLUCOSE. THE PATIENT INFORMED THE MSS THAT HE HAD 'INSULIN SHOCK' ON A SECOND OCCASION (UNKNOWN DATE/TIME) DUE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT A SECOND 'INSULIN SHOCK' EVENT OCCURRED AFTER HE CONSUMED DINNER IN A RESTAURANT. THE PATIENT REPORTEDLY TESTED HIS BLOOD GLUCOSE AFTER DINNER AND OBTAINED A BLOOD GLUCOSE RESULT OF '28 MG/DL' WITH THE SUBJECT METER. IT IS NOT KNOWN IF THE PATIENT TREATED HIMSELF OR RECEIVED MEDICAL INTERVENTION AT THAT TIME. IT IS ALSO NOT CLEAR IF ANY CHANGES WERE MADE TO THE PATIENT'S DIABETES MANAGEMENT THAT COULD HAVE LED TO THE '28 MG/DL' RESULT OR IF HE WAS EXPERIENCING SYMPTOMS AT THAT TIME. DURING TROUBLESHOOTING THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE TEST STRIPS WERE NOT EXPIRED. THE PATIENT DID NOT HAVE CONTROL SOLUTION DURING TROUBLESHOOTING AND SO A CONTROL TEST COULD NOT BE PERFORMED. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. HOWEVER, REPLACEMENT PRODUCT WAS STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT FOR THE FOLLOWING CONCLUSION(S): THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS SUGGESTIVE OF A SERIOUS INJURY AND HAVING 'INSULIN SHOCK' AFTER THE ALLEGED ISSUE BEGAN. IN ADDITION, THE PATIENT REPORTEDLY PERFORMED A PRECISION TEST AND OBTAINED RESULTS THAT EXCEEDED LFS'S CRITERIA FOR PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3294713

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R