BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4133911 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26028
    Event Type
    Injury
    Date Received
    October 2, 2014
    Report Date
    September 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (11/13/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/29/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/3/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    FOLLOW-UP # 2 ¿ THE PATIENT¿S METER HAS BEEN RETURNED ON 12/9/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/22/2014 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 12/12/2014 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

    INCORRECTLY STATED THE PRODUCT AS METER. THE CORRECT PRODUCT ARE THE TEST STRIPS.

    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 LOW WHEN COMPARED AGAINST HIS FEELING/NORMAL RESULT(S) AND INACCURATELY HIGH WHEN COMPARED AGAINST ANOTHER DEVICE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2014 (TIME NOT SPECIFIED). AT UNSPECIFIED DATES/TIMES THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿34MG/DL¿ AND READINGS IN THE 60¿S WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH UNSPECIFIED SET DOSES OF NOVOLOG, FLEXPEN, AND LANTUS; HOWEVER, IN RESPONSE TO THE ALLEGED INACCURATE LOW ISSUE THE PATIENT REPORTEDLY CONSUMED MORE FOOD/DRINK AT UNSPECIFIED DATE/TIME AFTERWARDS. BETWEEN THE END OF (B)(6), THE PATIENT REPORTEDLY BEGAN ¿PASSING OUT¿ AND SOMETIME IN AUGUST THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READING S OF ¿21, 29, AND 80MG/DL¿ WITH THE EMS¿S METER AND WAS ADMINISTERED AN UNKNOWN TYPE OF TREATMENT BY THE HEALTH CARE PROFESSIONAL (HCP). ON AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY OBTAINED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿470 AND 292MG/DL¿ WITH THE SUBJECT METER AND ¿123 AND 211MG/DL¿ WITH THE RELY ON METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF SOME OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. AT AN UNSPECIFIED DATE/TIME IN (B)(6) 2014, THE PATIENT REPORTEDLY CONTINUED WITH HIS USUAL DOSES OF MEDICATION IN RESPONSE TO THE ALLEGED INACCURATE HIGH ISSUE, AND SUBSEQUENTLY AN HOUR LATER, THE PATIENT ALLEGEDLY DEVELOPED A SYMPTOM OF SHAKING. ACCORDING TO THE CSR¿S DOCUMENTATION, ON AN UNSPECIFIED DATE/TIME IN (B)(6) 2014, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER). DURING HIS TIME IN THE ER HE REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿53, 29 OR 21MG/DL¿ WITH THE ER¿S METER AND WAS ADMINISTERED TREATMENT (TYPE UNKNOWN) BY THE HCP. 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. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614976 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3589591

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R