BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2211068 · Received August 14, 2011

    Report

    Report Number
    2531779-2011-05864
    Event Type
    Malfunction
    Date Received
    August 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP (B)(4) HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(4).

    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: PRIOR INVESTIGATION FOUND THERE WAS NO EVIDENCE OF DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND NO CORROSION WAS FOUND IN THE BATTERY COMPARTMENT. ALL PUMP CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS. THE PUMP WAS OPENED FOR INVESTIGATION AND NO FURTHER MOISTURE OR CORROSION DAMAGE WAS FOUND. THE POWER CIRCUIT WAS INSPECTED AND NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE PUMP EMITTED FREQUENT REPLACE BATTERY ALARMS (EVERY TWO WEEKS, INTERMITTENTLY) AND THAT MULTIPLE BATTERIES FELT HOT WHEN REMOVED. A FAMILY MEMBER STATED THAT THE PATIENT USED 12 BATTERIES (B)(6) 2011. SHE REPORTED THAT THE PATIENT USED ULTIMATE LITHIUM L91, THE BATTERY TYPE WAS CORRECTLY PROGRAMMED, THERE WERE NO UNCONFIRMED ALARMS, AND THE BATTERY CAP FIT SECURELY TO THE PUMP. THE FAMILY MEMBER CONFIRMED THAT NO ONE WAS INJURED RELATED TO THE HOT BATTERIES.

    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 12 YR