BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2854620 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14152
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTER INDICATED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR TESTING. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. A TEST CAP WAS INSERTED AND WAS ABLE TO SECURE TO THE PUMP. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS OBSERVED TO BE DELIVERING WITHIN SPECIFICATIONS; NO POWER EVENT OCCURRED DURING TESTING. THE PUMP WAS OPENED AND CONFIRMED THAT THERE WAS NO DAMAGE TO THE POWER CIRCUIT. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT HAD A BLOOD GLUCOSE OF 446 MG/DL WITH "SEVERE/MODERATE" KETONES. THE REPORTER STATED THAT THE BATTERY CAP WOULD NOT SECURE TO THE PUMP AND RESULTING IN THE PUMP LOSING POWER. TROUBLESHOOTING INDICATED THAT THE PUMP CASING WAS VISIBLY CRACKED AND THE YELLOW O-RING WAS SHOWING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening