BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4670725 · Received April 9, 2015

    Report

    Report Number
    2939301-2015-14282
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    March 24, 2015
    Report Date
    April 1, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(6) 2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE METER 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: SUPPLEMENTAL REPORT ((B)(6) 2015). IN ADDITION, THE PATIENT ALSO ALLEGED THE SUBJECT METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY ALSO BEGAN ON (B)(6) 2015. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿242, 262, 191, 204 AND 168 MG/DL¿ WITH THE SUBJECT METER. DURING THE FOLLOW-UP CALL, THE PATIENT FURTHER DESCRIBED HER SYMPTOM OF ¿CAN¿T FUNCTION WELL¿ AS BEING ¿DISORIENTATED, SHAKY AND DIZZY¿. THE PATIENT ALSO REPORTED TAKING ASPIRIN AS TREATMENT AND CLAIMED SHE FELT BETTER AFTERWARDS. DURING TROUBLESHOOTING, THE CSR ALSO CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AT THE TIME OF TESTING. THE CSR NOTED THE TEST STRIPS APPEARED IN GOOD CONDITION, WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DISPLAYED AN ¿ERROR 1¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN MEDICAL SURVEILLANCE REQUESTED CUSTOMER SERVICES FOLLOW-UP WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2015 WHEN SHE ATTEMPTED TO MEASURE HER BLOOD GLUCOSE, AND AN ERROR 1 MESSAGE WAS DISPLAYED. THE PATIENT STATED THAT SHE MANAGES HER DIABETES USING A COMBINATION OF ORAL MEDICATIONS AND INSULIN, AND SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF ¿CAN¿T FUNCTION, WOOZY AND TIRED¿ AN UNKNOWN AMOUNT OF TIME AFTER THE ALLEGED METER ISSUE BEGAN, AND REPORTEDLY SELF-TREATED BY CONSUMING ADDITIONAL FOOD AND/OR DRINK ON (B)(6) 2015 IN RESPONSE TO THE REPORTED ISSUE. DURING FOLLOW-UP WITH THE PATIENT SHE DESCRIBED "CAN'T FUNCTION" AS "WAS WALKING TO WALLS, DID NOT DRIVE, DISORIENTATED, DIDN'T FEEL 100%". THE PATIENT CONFIRMED THAT HER BLOOD GLUCOSE WAS NOT MEASURED USING ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THAT IT WAS NOT THE FIRST USE OF THE PRODUCT AND THERE WAS NO INDICATION OF ANY MISUSE OF THE DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236663 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3770386

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R