BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4191622 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28331
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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 ¿ (12/04/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/24/2014 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 HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH WHILE USING ONETOUCH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT 12 AND 1 PM. THE REPORTER STATED SHE OBTAINED AN INACCURATE HIGH CONTROL SOLUTION RESULT OF ¿147 AND 149MG/DL¿ ON THE SUBJECT METER. THE ALLEGED RESULT FALLS OUTSIDE THE CONTROL SOLUTION RANGE FOR THIS PRODUCT. THE PATIENT TAKES INSULIN TO MANAGE HER DIABETES AND SHE DENIED TAKING ANY ACTION TO HER REGULAR DIABETES MANAGEMENT ROUTINE AS A RESULT OF THIS ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED AN HOUR AND A HALF AFTER THE PRODUCT ISSUE OCCURRED SHE DEVELOPED THE SYMPTOM OF ¿SWEATING¿. HOWEVER, SHE DENIED RECEIVING ANY TREATMENT FOR THE SYMPTOM. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT UNIT OF MEASURE WAS USED AT THE TIME OF TESTING. IT WAS ALSO NOTED THAT THE INCORRECT TESTING PROCEDURE WAS USED AT THE TIME OF TESTING. THE PATIENT ¿DID NOT PREPARE THE SOLUTION¿. THE CCA ALSO NOTED THAT THE PATIENT NO LONGER HAD CONTROL SOLUTION. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED; THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: BASED ON THE INFORMATION PROVIDED, THE PATIENT DID SUFFER SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE ALLEGED PRODUCT ISSUE WITH THE LFS DEVICE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670917 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3475753

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening