BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4212224 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29064
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 22, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/18/2015). THE PATIENT¿S METER HAS BEEN RETURNED ON 2/2/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 2/5/2015 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 01/16/2015 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY LOW COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) TO CONDUCT FOLLOW UP QUESTIONS. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN AT 9:30AM ON (B)(6) 2014. AT THIS TIME THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿10MMOL/L¿ ON THE SUBJECT METER AND ¿15MMOL/L¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT INFORMED THE CSR THAT SHE REGULATES HER DIABETES BY SELF-ADJUSTING HER INSULIN DOSAGE. AT 9:30AM THAT MORNING THE PATIENT HAD TAKEN 8 UNITS OF HUMALOG INSULIN RATHER THAN HER USUAL DOSAGE OF 6 UNITS BECAUSE SHE HAD PREVIOUSLY DRANK GLUCOZADE THAT MORNING AT AROUND 7:45AM. DURING THE INITIAL CALL WITH THE CSR THE PATIENT REPORTED FEELING ¿THIRSTY¿, SHE ALSO HAD ¿SORE LIPS¿ AND SHE FELT ¿TIRED¿. SHE EXPERIENCED THESE SYMPTOMS AT 11:30AM AND ASSOCIATED THEM WITH HIGH BLOOD GLUCOSE. IT WOULD HAVE BEEN BENEFICIAL TO KNOW WHAT TREATMENT (IF ANY) THE PATIENT TOOK IN RESPONSE TO THESE SYMPTOMS, BUT THE MSS WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN THIS INFORMATION. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO WALK THROUGH A RETEST. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATELY LOW READING ON THE SUBJECT METER WHICH LED TO HER SUFFERING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696133 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3589824

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening