BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221660 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06171
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 10/03/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/07/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY SHOWED THAT REBOOTING HAD OCCURRED. THERE WERE NO RECORDED LOW OR REPLACE BATTERY ALARMS ON THE DATE OF THE REPORTED EVENT. CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP AND THE PUMP POWERED ON NORMALLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR ALARMS. THE BATTERY CAP WAS TESTED AND NO CONNECTION DEFECTS WERE FOUND. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. REBOOTING WAS VERIFIED IN THE BLACK BOX HISTORY BUT WAS NOT DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP SCREEN WAS BLANK BUT THE PUMP WAS BEEPING. THE FAMILY MEMBER REPORTED THAT THE BEEPS SOUNDED LIKE A LOW BATTERY ALARM. THE FAMILY MEMBER CHANGED THE BATTERY TWICE AND THE SECOND TIME THE PUMP POWERED ON SUCCESSFULLY. (B)(4) REVIEWED THE PUMP ALARM HISTORY WITH THE FAMILY MEMBER AND IT INDICATED THAT THE PUMP ALARMED FOR A LOW BATTERY TWICE BUT DID NOT INDICATE A REPLACE BATTERY ALARM HAD OCCURRED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP DID NOT ALARM TO ALERT THE USER TO REPLACE THE BATTERY.

    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 7 YR