BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2014030 · Received March 10, 2011

    Report

    Report Number
    2939301-2011-02072
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. LIFESCAN WAS UNABLE TO PERFORM TESTING WITH THE RETURNED TEST STRIPS SINCE THE VIAL WAS RETURNED EMPTY. 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

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S FAMILY MEMBER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE LAY USER/PATIENT'S FAMILY MEMBER WAS UNABLE TO CONTINUE WITH TROUBLESHOOTING AND THE CALL WAS TERMINATED. THE LAY USER/PATIENT'S FAMILY MEMBER CONTACTED LFS A SECOND TIME ON (B)(6) 2011 WITH THE SAME ALLEGED ISSUE AND WAS ABLE TO PROVIDE ADDITIONAL INFORMATION. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT AND/OR REPORTER BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 1:30PM. IT IS NOT KNOWN WHAT THE PATIENT¿S BLOOD GLUCOSE RESULT WAS AT THE TIME THE ALLEGED ISSUE BEGAN. THE REPORTER INDICATED THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER) AND AN HOUR AND A HALF PRIOR TO THE ALLEGED ISSUE, THE REPORTER INDICATED THE PATIENT ADMINISTERED HIS PREFILLED PEN OF HUMALOG MIX 75/25 INSULIN; IT IS NOT KNOWN, HOWEVER, WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS PRIOR TO ADMINISTERING HIS INSULIN. THE PATIENT'S TESTING AND MEDICATION FREQUENCIES ARE NOT KNOWN. IT IS UNCLEAR WHAT ACTION, IF ANY, THE PATIENT TOOK IN REGARDS TO HIS DIABETES MANAGEMENT AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE CSR'S DOCUMENTATION, THIRTY MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF BLURRY VISION AND DIZZINESS. IT IS NOT KNOWN IF THE PATIENT TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AFTER THE ONSET OF HIS SYMPTOMS. IT IS ALSO NOT KNOWN IF THE PATIENT ATTEMPTED TO ADMINISTER SELF-TREATMENT FOLLOWING HIS REPORTED SYMPTOMS. AT AN UNSPECIFIED TIME THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "340MG/DL" WITH THE SUBJECT METER AND AT 2:30PM (DURING THE PATIENT'S DOCTOR'S OFFICE VISIT) THE PATIENT OBTAINED A READING "64MG/DL" ON HIS DOCTOR/CLINIC'S METER, REPORTEDLY PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. PER CSR NOTES, THE PATIENT WAS ADMINISTERED FOOD AND/OR DRINK AS TREATMENT BY A HEALTH CARE PROFESSIONAL (HCP) AT THE SAME TIME AFTER OBTAINING THE READING WITH THE DOCTOR/CLINIC'S METER. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND WAS REPORTEDLY TREATED BY AN HCP FOR HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3071888

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R