BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2221995 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06187
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE NOTED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES FOUND. INVESTIGATION REVEALED THAT THE KEYPAD IS TORN OVER THE DOWN ARROW KEYPAD BUTTON. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. INVESTIGATION REVEALED THAT THE OK AND DOWN ARROW KEYPAD BUTTONS ARE INTERMITTENTLY UNRESPONSIVE. DURING THE ORIGINAL CALL WITH ANIMAS CUSTOMER SUPPORT, THE PATIENT CONFIRMED THAT HE HAD BEEN CHECKING TO BE SURE ALL BOLUSES WERE PROGRAMMED CORRECTLY. THERE IS NO ALLEGATION OR INDICATION THAT THE REPORTED KEYPAD ISSUE CONTRIBUTED TO THE PATIENT'S REPORTED BLOOD GLUCOSE EXCURSIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS ALLEGING HIS BLOOD GLUCOSE HAS BEEN ELEVATED DURING THE MONTH OF (B)(6) 2011. IN ADDITION, OVER (B)(6) THE PATIENT HAS BEEN HAVING ISSUES WITH RESPONSIVENESS OF THE KEYPAD BUTTONS. THE PATIENT REPORTEDLY MANAGES HIS BLOOD GLUCOSE WITH INSULIN VIA BOTH SYRINGE AND THE ANIMAS PUMP. ON (B)(6) 2011, THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 550 MG/DL AT 4:07 PM. OVER THE NEXT TWO HOURS, HE WAS ABLE TO LOWER HIS BLOOD GLUCOSE TO 69 MG/DL. REPORTEDLY, HIS BLOOD GLUCOSE HAS BEEN ABOVE 200 MG/DL. ON (B)(6) 2011, THE PATIENT TESTED AT 215, 449, 437 AND 200 MG/DL. ON (B)(6) 2011, THE PATIENT TESTED AT 329, 324, AND 170 MG/DL. ON (B)(6), THE PATIENT REPORTEDLY WAS ABLE TO MANAGE HIS BLOOD GLUCOSE AT 222 AND 127 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENTS ALLEGED HIGH BLOOD GLUCOSE BY EVALUATING THE ANIMAS PUMP. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE PATIENT CHANGES HIS INFUSION SITE EVERY 2-3 DAYS. THE ANIMAS REPRESENTATIVE ADVISED THE PATIENT TO CONTACT HIS HEALTHCARE PROVIDER TO OBTAIN A BACKUP PLAN. THE SUBJECT PUMP WILL BE RETURNED FOR INVESTIGATION. IT IS NOT CLEAR WHAT CONTRIBUTED TO THE PATIENT'S ELEVATED BLOOD GLUCOSE READINGS OVER THE MONTH OF (B)(6) 2011. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUE AND BECAUSE THE PATIENT ALLEGEDLY HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL ON (B)(6) 2011 WHILE HE MANAGED HIS BLOOD GLUCOSE WITH THE ANIMAS PUMP.

    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 82 YR Life Threatening| R