BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181079 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05357
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY RELATED TO THE COMPLAINT OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A LOW CARTRIDGE WARNING OCCURS AT 12:25 AM ON (B)(6) 2011. THE LOW CARTRIDGE WARNING WAS UNCONFIRMED UNTIL A REPLACE BATTERY ALARM OCCURS AT 2:10 AM. THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE BATTERY COMPARTMENT AND CAP ARE INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE INGRESS OBSERVED. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 4 HOURS, NO OVERHEATING OR ALARMS WERE DUPLICATED. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED; NO EVIDENCE OF MOISTURE INGRESS WAS FOUND. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS; NO DEFECTS WERE FOUND. THE COMPLAINT REGARDING PUMP AND BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS TO REPORT THAT THE PUMP AND BATTERY WERE VERY HOT TO THE TOUCH. THE PATIENT DENIED ANY INJURY OR BURNS TO THE SKIN. THE PATIENT CLAIMED SHE REPLACED PUMP'S BATTERY. THE PATIENT DENIED CORROSION IN BATTERY COMPARTMENT.

    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 27 YR