BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2565118 · Received May 8, 2012

    Report

    Report Number
    2939301-2012-04931
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Report Date
    May 1, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    (B)(4). ADDITIONAL INFORMATION: THE SERIAL NUMBER TO THE METER INVOLVED WITH THIS COMPLAINT IS (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE METER WAS FOUND TO TEST WITHIN OPERATING PARAMETERS. THE TEST STRIPS WERE ALSO RETURNED. HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER ISSUE ONLY. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER HAS LINES GOING THROUGH THE DISPLAY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 7-8X DAILY AND MANAGES HIS DIABETES WITH HUMALOG INSULIN. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 6PM. THE REPORTER CONFIRMED THE PATIENT CONTINUED TO TEST HIS BLOOD GLUCOSE USING ONE OF THE MANY BACKUP METERS AVAILABLE TO HIM. THE REPORTER DENIED THE PATIENT MADE CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE. IN EARLY APRIL 2012, THE REPORTER CLAIMS THE PATIENT DEVELOPED SYMPTOMS OF DIABETIC KETOACIDOSIS (DKA). THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "183, 152 AND 400 MG/DL" WITH ANOTHER DEVICE. THE REPORTER DENIED TESTING WITH THE SUBJECT METER AT THE TIME OF THE INJURY. THE PATIENT WAS ADMINISTERED HUMALOG INSULIN (6 UNITS TOTAL) BY THE TIME HE GOT TO THE EMERGENCY ROOM (ER). THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND ADMINISTERED INTRAVENOUS (IV) FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER CONFIRMED THE PATIENT CONTINUED TESTING HIS BLOOD GLUCOSE USING A NON-LFS BRAND METER. THE PATIENT DID NOT ATTEMPT TO TEST WITH THE SUBJECT METER BEFORE OR DURING THE TIME OF CONCERN; THEREFORE, THE LFS BLOOD GLUCOSE METER WAS NOT THE CAUSE OF THE REPORTED INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED DISPLAY ISSUE REMAINED UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR