BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3851172 · Received June 5, 2014

    Report

    Report Number
    2939301-2014-13481
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (07/14/2014).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 7/2/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/3/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/02/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND EVALUATED ON 06/21/2014 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE FIRST BEGAN ON (B)(6) 2014, AT 7AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION THREE AND A HALF HOURS AFTER THE ALLEGED ISSUE FIRST BEGAN, THE PATIENT REPORTEDLY PASSED OUT. THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND SOON AFTER (PERFORMED WITHIN 30 MINUTES OF EACH OTHER) THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿345MG/DL¿ WITH THE SUBJECT METER AND ¿185MG/DL¿ WITH THE EMS¿S METER. THE CSR NOTED THE PATIENT HAD RECEIVED IV GLUCOSE AS TREATMENT. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT¿S TESTING FREQUENCY AND TYPICAL BLOOD GLUCOSE RANGE; IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS; WHAT HER BLOOD GLUCOSE READING WAS AT THE TIME THE ALLEGED ISSUE FIRST BEGAN; PRIOR TO PASSING OUT WHAT WAS SHE DOING; WHAT THE PATIENT BELIEVE COULD HAVE CAUSED HER TO PASS OUT; WHO CONTACTED THE EMS; IF THE PATIENT WAS ADMINISTERED ANY TREATMENT PRIOR TO EMS ARRIVING; CONFIRMATION OF THE TIME DIFFERENCE BETWEEN THE TWO REPORTED RESULTS AND IF THE REPORTED READINGS WERE TAKEN AFTER THE PATIENT RECEIVED TREATMENT; AND IF THE PATIENT REQUIRED ADDITIONAL MEDICAL INTERVENTION. 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, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED A SYMPTOM INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329922 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3586663

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening