BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2875030 · Received December 17, 2012

    Report

    Report Number
    2531779-2012-14619
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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

    FOLLOW-UP #1: DATE OF SUBMISSION: (B)(4) 2013, DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED A DELIVERY INTERRUPTION FOR 2 HOURS DURING A CARTRIDGE CHANGE ON (B)(6) 2012, FROM 07:26AM TO 07:47AM AND FROM 9:11AM TO 10:59AM. THE TOTAL DAILY DOSE WAS FOUND TO BE BELOW THE PROGRAMMED TARGET RATE ON (B)(6) 2012; THE TDD OTHERWISE ADDED UP CORRECTLY. A REVIEW OF THE BLACK BOX HISTORY REVEALED A MANUAL DATE CHANGE FROM (B)(6) 2012, AT 10:36AM, ON THE REPORTED EVENT DATE. THE PUMP POWERED ON WITH NO ISSUES AND THE "EZ-PRIME" STEPS WERE SUCCESSFULLY PERFORMED. THE PUMP WAS FOUND TO STILL BE ABLE TO PRIME DURING INVESTIGATION. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. THE PUMP'S COVER WAS REMOVED AND THE FORCE SENSOR PINS TIGHTLY SECURED TO THE PCB. THE FORCE SENSOR FLEX PINS WERE FOUND TO BE INTACT AND NO DEFECTS WERE NOTED TO THE FORCE SENSOR CIRCUIT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS FOR ASSISTANCE WITH INSERTING A NEW INFUSION SET, AND DURING THE PROCESS THE PATIENT'S BLOOD GLUCOSE (BG) WAS DROPPING. THE PATIENT STATED THAT SHE HAD CHANGED THE CARTRIDGE AND INFUSION SET THAT MORNING BUT THE INFUSION SET FELL OFF, SO SHE CONTACTED ANIMAS FOR ASSISTANCE IN INSERTING A NEW SET. DURING THE CALL, THE PUMP REPORTEDLY EMITTED A "NO CARTRIDGE DETECTED" WARNING. THE PATIENT STATED THAT THE CARTRIDGE HAD JUST BEEN FILLED EARLIER THAT MORNING AND IT IS NOW EMPTY. THE PATIENT COULD NOT RECALL IF SHE HAD BEEN CONNECTED TO THE PUMP DURING THE INITIAL REWIND, LOAD, AND PRIME SEQUENCE WHEN SHE FIRST CHANGED SUPPLIES THAT MORNING. THE PATIENT NOTED THAT HER BG UPON WAKING THAT MORNING WAS 300MG/DL AND THAT AT THE TIME OF THE CALL WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (CTS) HER BG WAS 79MG/DL. CTS ADVISED THE PATIENT TO SEEK ASSISTANCE AT THE ER SINCE SHE MAY HAVE RECEIVED AN UNKNOWN AMOUNT OF ADDITIONAL INSULIN IF SHE WAS ATTACHED DURING THE REWIND/LOAD/PRIME SEQUENCE EARLIER THAT MORNING. A FOLLOW-UP CALL WITH THE PATIENT INDICATED THAT THE PATIENT'S BG HAD DROPPED TO 60MG/DL, AND THAT THE PATIENT HAD BEEN GIVEN ORANGE JUICE AND WAS BEING MONITORED BY A NURSE IN THE ER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG AND SOUGHT MEDICAL ASSISTANCE, AND BECAUSE THE PUMP MAY HAVE DISPENSED INSULIN DURING THE LOAD STEP.

    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 45 YR Life Threatening| R