BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2874594 · Received December 15, 2012

    Report

    Report Number
    2531779-2012-14600
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    December 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1: SUBMITTED (B)(6) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING RESULTS: NO INSULIN DELIVERY DEFECT WAS FOUND. THE PUMP PASSES 29H FLOW ACCURACY TEST TO CONFIRM THAT IT IS ABLE TO DELIVER WITHIN THE REQUIREMENT. HISTORY REVIEW SHOWS THAT TOTAL DAILY INSULIN DELIVERIES ADD UP CORRECTLY AND REFLECT USER'S PROGRAMMED BASAL RATES TARGETS. THE PUMP POWERS "ON" AND PRIMES NORMALLY. THE UNIT WAS EXERCISED FOR 24HRS, NO ALARMS OCCURRED DURING TESTING. OPENED THE PUMP, NO INTERMITTENT CONDITION IS FOUND TO THE FLEXES OR TO THE PCB. NO MOISTURE INGRESS IS OBSERVED INSIDE THE UNIT. THE FORCE SENSOR CALIBRATION READING IS ABOVE NORMAL SPECIFICATIONS. THE FORCE SENSOR RESISTANCE IS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT THE PUMP WAS NOT DELIVERING INSULIN RESULTING IN A BLOOD GLUCOSE OF 22.5 MMOL/L WITH FREQUENT URINATION. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THE PATIENT REPORTED THAT A BOLUS WAS DELIVERED AND THREE HOURS LATER, THE BLOOD GLUCOSE DID NOT GO DOWN. THE PATIENT REPORTED NO KNOWN ISSUES WITH SCAR TISSUES OR ISSUES AT THE SITE. THE PUMP WAS REVIEWED WITH THE PATIENT. THE PATIENT CONFIRMED THAT ALL OF THE PUMP SETTINGS WERE CORRECT, THE TOTAL DAILY DOSE HISTORY ADDED UP CORRECTLY, THERE WERE NO RELEVANT ALARMS IN THE PUMP HISTORY. THE PATIENT INDICATED THAT THERE WAS ONE SUSPEND IN THE PUMP HISTORY WHEN THE PATIENT TOOK A SHOWER; NO OTHER SUSPECTS WERE NOTED. TROUBLESHOOTING FOUND NO INDICATION OF ANY DEFECTS WITH THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION OF A PUMP DELIVERY ISSUE.

    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