BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2083352 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03292
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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: PUMP BOOTS UP TO 'VERIFY' SCREEN WIT H FUNCTIONAL DISPLAY AND AUDITORY/VIBRATORY ALARM WARNINGS. THE PUMP BLACKBOX SUGGESTED AN UNCONFIRMED EMPTY CARTRIDGE WARNING AT (B)(6) 2011 01:08. THE PUMP ENTERED A REBOOT CYCLE AT (B)(6) 2011 12:09 UNTIL (B)(6) 2011 13:42. DURING INVESTIGATION, PUMP ACCURATELY DELIVERS 1 UNIT/HR FOR 24 HOURS WITHOUT INTERRUPTIONS. NO DEFECTS WERE FOUND DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE ANIMAS INSULIN PUMP HAS A POWER ISSUE. REPORTEDLY, THE SCREEN ON THE PUMP GOES BLANK AND DOES NOT RESPOND. THERE WAS NO REPORT OF ANY SYMPTOMS OR MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. THE PATIENT IS ON A BACKUP PLAN FOR DIABETES TREATMENT. DURING TROUBLESHOOTING, THE ANIMAS NOTED THE FOLLOWING: THE BATTERY WAS REPLACED. THE BATTERY SPRING, THREADS AND COMPARTMENT IS IN GOOD CONDITION. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR