BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850128 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15836
    Event Type
    Injury
    Date Received
    June 4, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS TIME AND DATE RESETTING TO DEFAULT FOLLOWING A POR ON (B)(4) 2014 AT 4:240PM. A MANUAL TIME CHANGE OBSERVED FROM (B)(6) 2007 11:32PM TO (B)(6) 2014 10:16AM. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO TIME/DATE ISSUE.. REPLACE BATTERY ALARM ON (B)(6) 2014 AT 5:32AM, INSULIN DELIVERY IS NOT RESUMED UNTIL (B)(6) 2014 AT 8:30AM.. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. REPLACE BATTERY ALARM DUPLICATED DURING TESTING. PUMP GIVES APPROPRIATE AUDIBLE AND VISUAL ¿REPLACE BATTERY¿ ALARM.. PUMP TIME AND DATE WAS SET; PUMP EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED. PUMP LEFT WITHOUT POWER FOR 6 HOURS; WHEN PUMP POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP OPENED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. UNRELATED TO THE COMPLAINT, THE DISPLAY IS DIM; LETTERS HAVE A RED HUE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD RECEIVED TREATMENT ON (B)(6) 2014 FOR A BLOOD GLUCOSE (BG) >400 MG/DL WITH UNSPECIFIED KETONES AND SYMPTOMS OF DEHYDRATION. THE PATIENT WAS HOSPITALIZED WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THE BASAL DELIVERY TOTALS IN TDD DO NOT MATCH ACTIVE BASAL PROGRAM TOTAL AND THERE WAS NO KNOWN CAUSE FOR VARIATION. THE PUMP IS BEING REPLACED AND THE PATIENT IS BEING TREATED WITH IV FLUIDS AND INSULIN VIA PUMP AND INJECTION. THE PATIENT WAS INSTRUCTED TO DISCONTINUED PUMP USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE TDD DISCREPANCY WAS NOT RESOLVED AND THE PATIENT EXPERIENCED DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326361 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization