BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2830374 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13535
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. 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 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED EXCESSIVE FORCE TO ELICIT A RESPONSE; ALL OTHER BUTTONS RESPONDED APPROPRIATELY AND HAD NORMAL SPRING BACK/CLICK. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS STATING THAT THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE AND THE PATIENT WAS NOT RECEIVING THE CORRECT BOLUS DELIVERY AMOUNT. THE PATIENT'S BLOOD GLUCOSE (BG) AMOUNT WAS REPORTEDLY IN THE 17 TO 18 MMOL/L RANGE WITH THIRST ON (B)(6) 2012. THE PATIENT REPORTEDLY INCREASED HIS PHYSICAL ACTIVITY AND INCREASED THE BOLUS AMOUNT PER THE ADVISEMENT OF THE HEALTH CARE PROVIDER (HCP) AND THE PATIENT'S BG REPORTEDLY DECREASED IN THE 5 MMOL/L TO 8 MMOL/L RANGE ON THE NIGHT OF (B)(6) 2012 AND THE MORNING OF (B)(6) 2012. IT WAS NOTED THAT THE PUMP AND PATIENT WERE UNAVAILABLE FOR TROUBLESHOOTING. THE PATIENT REPORTEDLY CLEANED THE PUMP WITH A DAMP CLOTH AND WORE THE PUMP ATTACHED TO A BELT. THE REPORTED BG EVENT DOES NOT MEET THE ANIMAS DEFINITION OF AN ADVERSE MEET. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD 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 11 YR