BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2954990 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01680
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/21/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO ACTIVITY OUTSIDE NORMAL USE IS OBSERVED IN THE BLACK BOX RECORD. NO UNUSUAL VOLTAGE DROPS WERE NOTED AND NO BATTERY WAS RETURNED WITH THE PUMP. THE PUMP BOOTS UP NORMALLY AND IS ABLE TO PRIME SUCCESSFULLY AND NO OVERHEATING DUPLICATED. THE CURRENT DRAWS WERE TAKEN USING AN EXTERNAL POWER SUPPLY; ALL CURRENT READINGS ARE WITHIN NORMAL SPEC .THE PUMP WAS OPENED AND INSPECTED, THE POWER FLEX AND PCB WERE INSPECTED, NO INTERMITTENT CONDITION OR MOISTURE INGRESS WERE FOUND TO THE UNIT. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS HOT TO TOUCH. THE PATIENT STATED THAT THE BATTERY, BATTERY CAP AND PUMP WERE VERY HOT TO TOUCH. THE PATIENT STATED THAT THE PUMP FELT NORMAL TEMPERATURE LAST NIGHT BEFORE BED. THE PATIENT STATED THERE NO MOISTURE OR CORROSION NOTED IN THE BATTERY COMPARTMENT. THE PATIENT DENIED ANY FORM OF X-RAY OR MRI EXPOSURE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HOT PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59115 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR