BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2896972 · Received January 4, 2013

    Report

    Report Number
    2531779-2013-00179
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 4/16/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. ACCORDING THE BLACK BOX, LAST BASAL DELIVERY WAS ON (B)(4) 2012 AT 2:17PM, NO ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED. TDD ADD UP CORRECTLY AND REFLECT USER'S PROGRAMMED RATES. THE PUMP IS ABLE TO POWER UP TO "VERIFY" SCREEN. PERFORMED "EZ-PRIME" STEPS CORRECTLY .THE PUMP EXERCISES FOR 24HOURS AND PASSES 29 HOUR FLOW ACCURACY TEST. NO ALARM OCCURRED DURING TESTING. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. THE COVER WAS REMOVED, NO INTERMITTENT CONDITION OR MOISTURE INGRESS WAS OBSERVED TO THE FORCE SENSOR CIRCUIT OR TO THE POWER CIRCUIT. 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT HIS BLOOD GLUCOSE (BG) WAS ELEVATED TO 500 MG/DL THAT MORNING. THE PATIENT TREATED THE ELEVATED BG WITH A CORRECTION BOLUS VIA SYRINGE WHICH BROUGHT HIS BG DOWN TO 302 MG/DL AT THE TIME OF THE CALL TO ANIMAS. THE PATIENT ALLEGED THAT THE PUMP WAS NOT DELIVERING INSULIN CORRECTLY AND DISCONTINUED USE OF THE PUMP. THE PATIENT REPORTED THAT HE CHANGED THE INFUSION SET AND THAT DID NOT RESOLVE THE ISSUE. THE PATIENT DENIED ANY DAMAGE TO THE PUMP, MOISTURE TO THE PUMP OR X-RAY/MAGNETIC EXPOSURE. THE PATIENT STATED THAT ALL THE KEYPAD BUTTONS WERE FUNCTIONAL. ON REVIEW OF THE PUMP, THE PATIENT CONFIRMED THAT THE ADVANCED PUMP FEATURES WERE SET AS DESIRED AND THAT ALL THE BASAL RATES WERE CORRECT. REVIEW OF THE PUMP HISTORY DID NOT REVEAL ANY ALARMS AND VERIFIED THAT THE BOLUS HISTORY WAS CORRECT, THE BASAL HISTORY WAS CORRECT, THE TOTAL DAILY DOSE WAS CORRECT AND THE PRIME HISTORY WAS CORRECT. OF NOTE, NO CANNULA FILL WAS PERFORMED DURING THE MOST RECENT INFUSION SET CHANGE. THE SUSPEND HISTORY DID REVEAL AN UNKNOWN, UN-PROGRAMMED SUSPEND FROM 2:53 AM TO 2:58 AM ON (B)(6) 2012. TROUBLESHOOTING WAS UNABLE TO IDENTIFY A CAUSE FOR INACCURATE DELIVERY; HOWEVER, THE PATIENT STATED THAT NO LONGER TRUSTED THE PUMP AND REQUESTED A REPLACEMENT PUMP. THE PATIENT STARTED ON A BACKUP PLAN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG OF UNKNOWN ORIGIN AND MADE THE ALLEGATION THAT THE INSULIN PUMP WAS NOT PERFORMING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4845 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR