BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1342986 · Received March 11, 2009

    Report

    Report Number
    2939301-2009-01793
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    February 14, 2009
    Report Date
    February 18, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS 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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2009 AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WAS GIVING INACCURATE CONTROL HIGH READINGS. IT WAS NOTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOUR DAYS PRIOR, AND WAS TREATED WITH IV GLUCOSE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON MARCH 10, 2009 TO OBTAIN/VERIFY THE FOLLOWING INFORMATION. THE PATIENT CONFIRMED THAT THE REASON WHY HE CONTACTED LIFESCAN WAS BECAUSE, THE CONTROL SOLUTION TESTS WERE FAILING. THE PATIENT WAS UNABLE TO PROVIDE SPECIFIC CONTROL SOLUTION RESULTS. THE PATIENT INDICATED THAT THE ALLEGED ISSUE FIRST OCCURRED APPROXIMATELY THE MONTH PRIOR TO ORIGINAL MONTH, AND THE ISSUE HAS OCCURRED A FEW MORE TIMES ORIGINAL MONTH. THE PATIENT STATED HE WENT TO THE ER AS A RESULT OF A HYPOGLYCEMIC EVENT AND NOT A RESULT OF THE ALLEGED FAILED CONTROL SOLUTION TESTS. ON THE DAY OF THE HYPOGLYCEMIC EVENT, THE PATIENT OBTAINED A "475 MG/DL" ON HIS METER AT AROUND 4-5 AM ON EVENT DATE. HE REPORTEDLY WAS FEELING "CRAPPY," THIRSTY, AND WANTED TO SLEEP AT THE TIME OF THE TEST. HE TOOK 11 UNITS OF NOVOLIN R ACCORDING TO HIS SLIDING SCALE. ABOUT 1-2 HOURS LATER, HE RETESTED AND GOT A "HI" METER RESULT, WHICH INDICATED THAT HIS BLOOD GLUCOSE LEVELS WERE OVER 600 MG/DL. HE CONTACTED THE ON CALL DOCTOR AND HE WAS ADVISED TO TAKE AN ADDITIONAL 22 UNITS OF NOVOLIN R. BY THE TIME HE WOKE UP AT 6:30 AM, HIS BLOOD GLUCOSE LEVEL WAS AT "128 MG/DL" ON THE SUBJECT METER. HE REPORTEDLY HAD NO SYMPTOMS. HE CONTINUED TO TAKE HIS USUAL 22 UNITS OF LANTUS AND PROCEEDED TO EAT HIS "TYPICAL" BREAKFAST AROUND 8 AM. ABOUT 30 MINUTES AFTER THE BREAKFAST, HE DEVELOPED REALLY "BAD SWEATS AND THE SHAKES". HE TESTED ON THE SUBJECT METER AND GOT "18 MG/DL" AND "LO". HIS FRIEND CONTACTED THE EMERGENCY MEDICAL SERVICES (EMS). THE EMS TESTED HIS BLOOD GLUCOSE LEVELS AND THE RESULT WAS "LOW". THE EMS GAVE HIM A GLUCAGON INJECTION AND THEN TOOK HIM TO THE HOSPITAL. THE PATIENT WAS TREATED WITH IV GLUCOSE AT THE HOSPITAL AND WAS ADMITTED FOR 1 WEEK. AFTER THE INCIDENT, THE PATIENT'S DOCTOR ADJUSTED HIS NOVOLIN R SLIDING SCALE SO THAT THE PATIENT IS NOW TAKING LESS INSULIN THAN BEFORE THE INCIDENT. HE INDICATED THAT THE CHANGE WAS AS A RESULT OF HIS BLOOD GLUCOSE LEVELS NOT BEING SO HIGH NOW AND NOT A RESULT OF THE HYPOGLYCEMIC EVENT. AT THE TIME OF TROUBLESHOOTING, IT WAS DISCOVERED THAT THE METER WAS NOT CODED CORRECTLY (USE ERROR) TO MATCH THE CODE ON THE TEST STRIP VITAL. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGEDLY BECAME HYPOGLYCEMIC AFTER TAKING INSULIN BASED ON THE REPORTED METER RESULTS. HOWEVER, THE ALLEGATION OF INACCURATE CONTROL HIGH RESULT IS NOT REPORTABLE SINCE THE METER WAS NOT CODED CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2871439

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening