BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3192274 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09068
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED EVENT TYPE AND REPORTABLE TYPE: MALFUNCTION WAS INADVERTENTLY SELECTED IN THE REPORT SUBMITTED. A CHECK WAS INADVERTENTLY MISSED IN THE REPORTED OUTCOME OF EVENT. PLACED A CHECK MARK IN THE LIFE THREATENING BOX.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED NO ISSUES WITH ¿LOSS OF PRIME¿ ON THE REPORTED EVENT DATE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS FROM WERE FOUND TO BE WITHIN SPECIFICATION; ONLY TYPICAL USAGE WAS OBSERVED IN THE PUMP ALARM HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS; THE ¿PRIME¿ BOX ON THE EZ-PRIME SCREEN REMAINED FILLED DURING THE DURATION OF THE TEST AND NO ¿LOSS OF PRIME¿ WAS DUPLICATED. A ¿LOSS OF PRIME¿ WARNING WAS INDUCED DURING INVESTIGATION BY REMOVING THE CARTRIDGE; THE PUMP EMITTED THE APPROPRIATE ¿LOSS OF PRIME¿ WARNING AND DISPLAYED THE CORRECT MESSAGE ON THE PUMP DISPLAY SCREEN. THE PUMP WAS ALSO FOUND TO DETECT THE CORRECT FORCE DURING TESTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING THE INVESTIGATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 29MMOL/L. THE REPORTER STATED THE PATIENT CHANGED THE CANNULA ON (B)(6) 2013, THE PRIME BOX WAS NOT CHECKED IN THE PRIME MENU AND THE PUMP NEVER EMITTED A ¿LOSS OF PRIME¿ WARNING. THE REPORTER CLAIMED THE PATIENT¿S BG ELEVATED DUE TO CESSATION OF BASAL DELIVERY. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP TOTAL DAILY DOSE (TDD) HISTORY WITH THE REPORTER AND NOTED THAT THE BASAL DELIVERY WAS NOT SIGNIFICANTLY INTERRUPTED. CS ADVISED THAT IT WOULD HAVE BEEN DIFFICULT TO COMPLETE THE FULL REWIND, INSERT AND LOAD A NEW CARTRIDGE AND COMPLETE THE PRIME STEP WITHIN A MINUTE WHICH WAS INDICATED IN THE PRIME HISTORY. CS ALSO ADVISED THE CARTRIDGE CAP MAY HAVE NOT BEEN SECURED PROPERLY TO PUMP OR THE CARTRIDGE MAY HAVE BEEN OUT OF THE PUMP WHICH WOULD OF TRIGGERED AN IMMEDIATE LOSS OF PRIME AND PRIME BOX TO TO BE UNCHECKED. FURTHER TROUBLESHOOTING, INDICATED THE PATIENT PRIMED THE PUMP TWICE WITHIN THE SAME MINUTE AND SINCE BASAL TOTAL WAS NOT SIGNIFICANTLY REDUCED FOR THAT DAY IT WOULD NOT HAVE AFFECTED THE ELEVATED BG. CS ALSO NOTED TO THE REPORTER A LOSS OF PRIME WOULD HAVE BEEN TRIGGERED BY SOME OTHER ALARM FROM AN OCCLUSION ISSUE OR ANOTHER ISSUE. IT WAS NOTED BY CS THAT THERE WAS NO INDICATION OF A PUMP MALFUNCTION OR A CESSATION OF INSULIN DELIVERY. THERE WAS REPORTEDLY A PATTERN OF BG ELEVATIONS WHEN THE SITE WAS CHANGED. CS REPORTEDLY ADVISED THE REPORTER THERE MAY HAVE BEEN POSSIBLE ABSORPTION ISSUE AND RECOMMENDED TO CONSULT WITH THE HEATH CARE PROVIDER FOR ASSISTANCE ON CHANGING THE SITE AND LOCATIONS TO USE SINCE THE PATIENT ONLY USES THE ABDOMEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THAT THE REPORTER BELIEVED THE PUMP LOST PRIME AND DID NOT EMIT ANY ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292975 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening