BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2240311 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06665
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN THE BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT CLAIMED THAT SHE WOKE UP THAT MORNING AT 8:30 AM WITH A BG LEVEL OF "529 MG/DL". THE PATIENT REPORTEDLY TOOK 19 UNITS OF INSULIN WITH THE PUMP AFTER CHANGING THE SITE, SET, AND INSULIN. THE PATIENT THEN CALLED HER HEALTH CARE PROVIDER (HCP) AND TOOK ANOTHER 10 UNITS OF INSULIN AT 11:07 PM. THE HCP REPORTEDLY INSTRUCTED THE PATIENT TO CALL ANIMAS. THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE INVOLVED IN THE INITIAL CONTACT WITH PATIENT DETERMINED THAT THERE WAS NO EVIDENCE OF A MECHANICAL MALFUNCTION OF THE PUMP. THE TDD MATCHED. THE BASAL HISTORY APPEARED TO BE CORRECT. THERE WERE NO SIGNS OF AN ISSUE WITH THE PATIENT'S SITE, SET, CARTRIDGE, OR INSULIN. HOWEVER, THE PATIENT ADMITTED THAT HER LAST SITE CHANGE WAS ON (B)(6) 2011. THE ANIMAS REPRESENTATIVE INFORMED THE PATIENT THAT IT IS RECOMMENDED TO CHANGE THE SITE EVERY 3 DAYS OR EARLIER IF NEEDED. THE PATIENT DID NOT HAVE ANY CHANGES IN ACTIVITY OR MEDICATIONS. NO ILLNESSES WERE REPORTED. ON (B)(6) 2011, THE PATIENT WAS CONTACTED BY ANOTHER ANIMAS REPRESENTATIVE AS A FOLLOW-UP TO HER INITIAL CALL THE PREVIOUS DAY. THE PATIENT INDICATED THAT SHE WAS HOSPITALIZED ON (B)(6) 2011, FOR DKA AND BG LEVELS OVER "500 MG/DL." THE PATIENT WAS REPORTEDLY DISCONNECTED FROM THE PUMP ALTHOUGH THE SKIN SITE WAS NOT REMOVED. THE PATIENT CLAIMED THAT HER BG LEVEL CAME DOWN TO THE "300'S" WITH INSULIN INJECTIONS. THE PATIENT'S HCP REQUESTED FOR ANIMAS TO CONTACT THE PATIENT TO REVIEW THE PUMP. THE PATIENT REFUSED TO REVIEW THE PUMP DURING THE 2ND CONTACT WITH ANIMAS AND MENTIONED THAT SHE HAD ALREADY REVIEWED THE PUMP WITH THE PREVIOUS REPRESENTATIVE SHE SPOKE TO. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED ELEVATED BG LEVELS AND WAS HOSPITALIZED WHILE USING THE PUMP. THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR SINCE SHE WAS NOT CHANGING HER SITE(S) AS RECOMMENDED. THE PUMP WAS REPLACED.

    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 Hospitalization| L| R