BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2171831 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05114
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 07/30/2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THERE WAS NO DATA AVAILABLE IN THE DOWNLOAD HISTORY OR BLACK BOX FOR THE TIME OF THE REPORTED HIGH BGS DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT MANAGED HIS DIABETES WITH THE ANIMAS PUMP AND SUBSEQUENTLY WAS TREATED AT HOSPITAL WITH IV INSULIN FOR ELEVATED BLOOD GLUCOSE READING(S) ON (B)(6) 2011. DURING TROUBLESHOOTING, THERE WAS NO EVIDENCE THAT THE ANIMAS PRODUCT MALFUNCTIONED. THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY OF THE PUMP. ALL BOLUS AND BASAL INSULIN DELIVERIES ADD UP WITH THE TOTAL DAILY DOSE (TDD). THE DATE AND TIME WAS PROGRAMMED CORRECTLY. NO PRODUCT MISUSE WAS IDENTIFIED. PRIOR TO THE HOSPITALIZATION, THE PATIENT DID NOT BOLUS ON (B)(6) 2011. ON (B)(6) 2011 AT 10:11 AM AND 9:06 PM, THE PATIENT TOOK BOLUS INSULIN. THE PRIMING HISTORY SHOWS THE PATIENT DID NOT FULLY PRIME ON (B)(6) 2011. THE PATIENT REPORTEDLY CHANGED HIS SITE AND TUBING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY MANAGED HIS DIABETES WITH THE ANIMAS PRODUCT AND SUBSEQUENTLY RECEIVED MEDICAL INTERVENTION SUGGESTIVE FOR HYPERGLYCEMIA. THE CAUSATION OF THE ALLEGE HYPERGLYCEMIA MAY POSSIBLY BE USER ERROR AS THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. HENCE, THIS EVENT IS BEING REPORTED.

    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 66 YR Hospitalization| L| R