BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3950013 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20929
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2014 WITH THE FOLLOWING FINDINGS: THE PUMP SETTINGS SHOW THE LOW CARTRIDGE WARNING LEVEL WAS SET AT 20U. THE BLACK BOX SHOWS ON (B)(6) 2014 17:14 THAT APPROXIMATELY 46U REMAINED IN THE PUMP. AN UNEXPLAINED POR EVENT OCCURRED AT 17:18. THE PUMP WAS POWERED BACK ON AND PRIMED 45.49U AT 17:26. THE 45.49U PRIME BYPASSED THE LOW CARTRIDGE WARNING RESULTING IN AN EAW- 144 REPLACE CARTRIDGE ALARM AT 17:26. DELIVERIES RESUMED AT 18:17. A ¿REPLACE CARTRIDGE¿ ALARM AND A ¿LOW CARTRIDGE¿ WARNING WERE REPRODUCED FOR THE INVESTIGATION WITH THE SOUND SETTINGS SET TO HIGH; THE PUMP GAVE THE APPROPRIATE SOUND AND DISPLAYED THE CORRECT MESSAGE ON THE SCREEN. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PUMP DID NOT EMIT A LOW CARTRIDGE ALARM PRIOR TO THE EMPTY CARTRIDGE ALARM, AND THE PATIENT NOW HAS A 400 MG/DL BLOOD GLUCOSE (BG) WITH UNSPECIFIED KETONES. NO UNUSUAL TREATMENT WAS GIVEN, BUT THE BASAL RATE AND BOLUS SETTINGS WERE ADJUSTED. THE PATIENT HAS LOST CONFIDENCE IN THE PUMP AND REQUESTS REPLACEMENT. TROUBLE SHOOTING WITH CUSTOMER TECHNICAL SUPPORT DID NOT REVEAL ANY DELIVERY ISSUES BUT THE PATIENT DISCONTINUED PUMP THERAPY BECAUSE OF AN ALLEGED INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP CANNOT BE RULED OUT AS CAUSING/CONTRIBUTING TO THE HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428603 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening