BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6359202 · Received February 24, 2017

    Report

    Report Number
    2531779-2017-04379
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Report Date
    February 6, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 04/12/2017/ 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/16/2017 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS UNEXPLAINED POWER ON RESET ON (B)(6) 2017 AT 00:04. WHEN THE PUMP WAS POWERED BACK ON, THE TIME/DATE WAS SET INCORRECTLY TO 2007-01-01 00:08 AND DELIVERIES RESUMED. A MANUAL TIME/DATE CHANGE WAS LATER MADE FROM 2007-01-02 23:29 TO 2017-02-05 23:42. AN UNEXPLAINED POWER ON RESET OCCURRED ON (B)(6) 2017 AT 09:01 AND DELIVERIES NEVER RESUMED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE LAST BASAL DELIVERY WAS ON (B)(6) 2017. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. NO DEFECTS WERE FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED AND THE DISPLAY WAS DIM/FADED/DISCOLORED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED AS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141153 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR