BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2132059 · Received June 16, 2011

    Report

    Report Number
    2939301-2011-04926
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (07/27/2011) - DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S CAREGIVER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER WAS READING INACCURATELY COMPARED TO HIS FEELING/ NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT 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 9:30AM. THE REPORTER DOES NOT RECALL THE ALLEGED INACCURATE RESULT THE PATIENT OBTAINED WITH THE SUBJECT METER AND IT IS NOT KNOWN IF THE PATIENT CONTINUED TO USE THE SUBJECT METER AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER). IT IS UNCLEAR WHAT ACTION THE PATIENT TOOK AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE CSR'S DOCUMENTATION, TWO WEEKS AFTER THE ALLEGED METER ISSUE BEGAN (DATE/TIME NOT SPECIFIED) THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "SHAKING, TREMBLING". THE PATIENT"S BLOOD GLUCOSE RESULTS PRIOR TO AND/OR DURING HIS REPORTED SYMPTOMS ARE NOT KNOWN, IT IS NOT SPECIFIED IF THE PATIENT HAD MADE ANY CHANGES TO HIS DIABETES REGIMEN, MEALS, OR ACTIVITY LEVEL BEFORE HIS SYMPTOMS BEGAN, AND IF IT NOT SPECIFIED IF THE PATIENT ATTEMPTED TO ADMINISTER SELF-TREATMENT AFTER THE ONSET OF HIS SYMPTOMS. ON (B)(6) 2011, THE PATIENT REPORTEDLY CONSUMED LESS FOOD (AT 9AM); HOWEVER, IT IS NOT SPECIFIED IF THE PATIENT TESTED WITH THE SUBJECT METER AND WHAT HIS BLOOD GLUCOSE RESULT WAS PRIOR TO HIS ACTION. ACCORDING TO THE CSR'S DOCUMENTATION, SIX HOURS LATER THE PATIENT WAS REPORTEDLY ADMINISTERED IV FLUIDS BY A HEALTH CARE PROFESSIONAL (HCP) IN THE EMERGENCY ROOM (ER); THE REASON FOR THE ER VISIT IS NOT KNOWN. PRIOR TO GOING TO THE ER, IT IS NOT SPECIFIED WHAT THE PATIENT'S LAST BLOOD GLUCOSE RESULT WAS (WITH THE SUBJECT METER), WHAT ACTION THE PATIENT TOOK IN RESPONSE TO HIS PREVIOUS RESULT, AND WHAT SYMPTOM(S), IF ANY, THE PATIENT WAS EXHIBITING. DURING THE PATIENT'S TIME IN THE ER, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "465MG/DL" WITH THE ER'S METER (AT 3:30PM); IT IS NOT SPECIFIED IF THE PATIENT RECEIVED ANY OTHER FORM OF MEDICAL INTERVENTION AND IT IS NOT KNOWN WHEN THE PATIENT WAS RELEASED FROM THE ER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE REPORTER DID NOT HAVE ALL OF THE PATIENT'S TESTING SUPPLIES AVAILABLE. REPLACEMENT PRODUCTS WERE 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R