BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2181607 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06504
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. IN ADDITION, THE PATIENT REPORTED THAT THE METER BROKE AFTER DROPPING IT. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED INACCURACY ISSUE OCCURRED APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED THAT ON AN UNKNOWN DATE AND TIME IN THE EVENING, HE WAS EXPERIENCING SYMPTOMS OF "LOW SUGAR, SWEATY, SHAKY, AND IRREGULAR HEARTBEAT" PRIOR TO TESTING. HE THEN TESTED HIS BLOOD GLUCOSE USING THE SUBJECT METER (TIME UNKNOWN) AND REPORTEDLY RECEIVED A RESULT OF "500 MG/DL" WHICH THE PATIENT FELT TO BE HIGH COMPARED TO HIS SYMPTOMS AND NORMAL READINGS. THE PATIENT INFORMED THE MSS THAT HE MANAGES HIS DIABETES USING NOVOLOG INSULIN DURING MEAL TIMES AND TAKES APPROXIMATELY 3 UNITS FOR "REGULAR MEALS" AND 6 UNITS FOR MEALS WITH HIGH CARBOHYDRATES. HE STATED HE NORMALLY TESTS THREE TIMES PER DAY AND COULD NOT RECALL WHAT HIS BLOOD GLUCOSE READINGS WERE PRIOR TO RECEIVING THE ALLEGED "500 MG/DL" READING. THE PATIENT CLAIMED HE TOOK A "SMALL AMOUNT OF NOVOLOG INSULIN" BASED ON THE ALLEGED RESULT AND CLAIMED THAT THE SAME SYMPTOMS BECAME "MORE SEVERE". THE PATIENT THEN REPORTEDLY DRANK SOME "(B)(6) AND ATE SOMETHING SWEET" AND FELT BETTER AFTERWARDS. THE PATIENT ALLEGED THAT ON THAT SAME DAY, IN THE MIDDLE OF THE NIGHT HE WAS FEELING "SHAKY, HAD IRREGULAR HEART BEAT AND WAS SWEATY AGAIN." HE WENT TO TEST HIS BLOOD GLUCOSE ON THE SUBJECT METER AND DROPPED IT ON THE FLOOR RESULTING IN THE METER CRACKING INCLUDING THE METER'S DISPLAY. THE PATIENT REPORTEDLY TREATED HIMSELF AT THAT TIME BY EATING "SUGAR, CAKE, HONEY AND DRINKING (B)(6)" AND CLAIMED HIS SYMPTOMS CONTINUED. AT AN UNSPECIFIED TIME, THE PATIENT REPORTEDLY WAS TAKEN TO THE EMERGENCY ROOM (ER) BY HIS MOTHER DUE TO HIS SYMPTOMS. WHEN THE PATIENT ARRIVED AT THE ER, HE STATED BLOOD TESTS WERE PERFORMED ON THE ER METER (UNKNOWN TYPE) "EARLY IN THE MORNING" AT AN UNSPECIFIED TIME, AND REPORTED VALUES OF "25, 33, 35 MG/DL." THE PATIENT WAS REPORTEDLY TREATED WITH IV GLUCOSE IN THE ER AND WAS ADMITTED FOR 24 HOURS FOR OBSERVATION. THE PATIENT REPORTED THAT HE SAW HIS DOCTOR AFTER BEING RELEASED FROM HOSPITAL ON AN UNKNOWN DATE AND WAS PRESCRIBED 20 UNITS OF LANTUS INSULIN TO HIS DAILY REGIMEN. THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE RESULTS HAVE SINCE BEEN UNDER CONTROL AND HIS READINGS ARE IN THE "130 MG/DL" RANGE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED FOR THE INACCURACY COMPLAINT THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO CHECK THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND WAS TREATED BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3137654

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R