BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2388906 · Received December 27, 2011

    Report

    Report Number
    2939301-2011-12790
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE 510K#: K080639.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS 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) 2011 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER WAS GIVING THE ERROR 1 ERROR MESSAGE. THE (B)(4) WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 11:15 AM THE PATIENT OBTAINED THE ERROR 1 ERROR MESSAGE ON THE REPORTED METER; HE DID NOT OBTAIN A BLOOD GLUCOSE READING. AFTERWARDS, THE PATIENT WAS GIVEN AN INCREASED DOSE OF INSULIN VIA THE PUMP, 2.9 UNITS INSTEAD OF 1.55 UNITS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT AND HE DID NOT SUFFER ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT SUFFERED NO SYMPTOMS AND DID NOT RECEIVE ANY TREATMENT TO MITIGATE SEVERE INJURY. HOWEVER, AS THE METER ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3218933

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR