BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3222362 · Received July 12, 2013

    Report

    Report Number
    3008382007-2013-19468
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    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 # 1 ¿ (08/05/2013) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 (08/13/2013)-PRODUCT EVALUATIONN: THE TEST STRIP RETAIN HAS BEEN EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 08/07/2013 WITH THE FOLLOWING FINDINGS: THE ANALYSIS OF THE TEST STRIP RETAIN WAS NORMAL. NO ISSUES WERE FOUND. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON AN UNSPECIFIED DAY IN (B)(6) OF 2013. THE PATIENT REPORTED OBTAINING INACCURATE HIGH READINGS IN THE ¿HIGH 200S MG/DL¿ RANGE WITH THE SUBJECT METER. THE PATIENT INFORMED THE MSS THAT PRIOR TO WHEN THE ISSUE STARTED; HIS BLOOD GLUCOSE LEVELS WOULD TYPICALLY RUN IN THE RANGE OF ¿110 TO 160 MG/DL¿. THE PATIENT MANAGES HIS DIABETES WITH A SET DOSE OF LEVEMIR INSULIN AND ORAL MEDICATION (METFORMIN). THE PATIENT MENTIONED THAT HE CONTACTED HIS DOCTOR (DATE NOT PROVIDED) WHEN HE BEGAN TO OBTAIN THE ELEVATED READINGS AND WAS ADVISED TO TAKE 1 ADDITIONAL UNIT OF LEVEMIR INSULIN. ON THE EVENING OF (B)(6) 2013, THE PATIENT STATED HE TOOK AN ADDITIONAL UNIT OF INSULIN AS INSTRUCTED AND THE FOLLOWING MORNING HE WOKE UP NOT FEELING WELL. THE PATIENT REPORTED THAT HE FELT DIZZY, NAUSEOUS AND HAD COLD SWEATS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED HE WENT TO AN URGENT CARE CLINIC. THE PATIENT CLAIMED WHEN HE ARRIVED TO THE CLINIC HIS BLOOD GLUCOSE WAS TESTED WITH THE CLINIC METER AND THE READING REGISTERED IN THE ¿60¿S MG/DL¿. THE PATIENT STATED HE WAS TREATED WITH GLUCOSE TABLETS AND JUICE AND CONFIRMED FEELING BETTER AFTERWARDS. THE PATIENT REPORTED HIS BLOOD GLUCOSE WAS RETESTED AFTER TREATMENT AND THE RESULT WAS ¿120 MG/DL¿. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THE TEST STRIPS APPEARED IN GOOD CONDITION AND WERE NOT OPEN PAST THEIR DISCARD DATE. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING ALLEGED INACCURATE HIGH READINGS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323321 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3385957

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R