BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1884260 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09534
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 11/19/2010: 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. 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

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

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC WHEN COMPARING BLOOD GLUCOSE RESULTS TAKEN ONE AFTER ANOTHER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 3PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "266, 397 AND 482 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT STATES HE MANAGES HIS DIABETES WITH NOVALOG INSULIN (5 UNITS). THE PATIENT STATED HE CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. ABOUT 30 MINUTES AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED HE FELT SYMPTOMS OF WEAKNESS AND SHAKY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST WHICH FELL WITHIN THE RANGE PRINTED ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY AFTER THE IMPLANTATION OF ONE 2.5 X 28 XIENCE V STENT IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE 2.5 X 23 XIENCE V STENT IN THE MID LAD, THE PATIENT EXPERIENCED ANGINA, WAS FOUND TO HAVE ELEVATED CK-MB, AND WAS DIAGNOSED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION THAT WAS TREATED WITH NITROGLYCERIN. THE PATIENT'S CONDITION RESOLVED WITHOUT SEQUELA TWO DAYS POST PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    RECEIVED MESSAGE ON AFTER-HOURS ANSWERING SERVICE PT CALLED WITH (B)(4) 6000 ALARM ERROR CODE 46 - CLOCK NOT SET - WITH TPN SETUP (B)(6) 2010, PER RECENT INFO FROM MFR AND (B)(4) HELP LINE, THIS WAS NOTED TO BE A NON-FIXABLE PUMP PROBLEM AND ONLY OPTION IS TO GET REPLACEMENT PUMP TO PT FOR TPN INFUSION THAT NIGHT. ARRANGED AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3025985

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening