BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913805 · Received November 26, 2010

    Report

    Report Number
    2531779-2010-02561
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NON CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2010 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE "VERIFY" SCREEN WITH APPROPRIATE AUDITORY AND VIBRATORY ALARMS. THE TOTAL DAILY DELIVERY HISTORY SHOWED THAT THE PUMP WAS DELIVERING ACCURATELY. A FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED.

    Description of Event or Problem · 1

    THE PT REPORTED ELEVATED FASTING BLOOD GLUCOSE READINGS OVER THE PAST THREE TO FOUR WEEKS DESPITE BASAL RATE REMAINING UNCHANGED. HE STATED THAT HIS BLOOD GLUCOSE RANGE AT BEDTIME IS 90-120 MG/DL AND HIS USUAL FASTING BLOOD GLUCOSE IS 80-150 MG/DL. LATELY, HIS FASTING BLOOD GLUCOSE HAS BEEN AS HIGH AS 280 MG/DL AND DID NOT REPORT SYMPTOMS OF HYPERGLYCEMIA. HE HAS NOT REQUIRED MEDICAL INTERVENTION FOR THE ELEVATED BLOOD GLUCOSE LEVELS. THE PT REVIEWED THE PUMP AND SAID THAT THE TIME AND DATE ARE CORRECT AND THE BASAL RATES WERE PROGRAMMED AND DELIVERED CORRECTLY. THE PT DOES NOT USE PUMP TO DELIVER BOLUSES. HE NOTED NO SUSPENSIONS SINCE (B)(6) 2010; THERE WERE ONLY LOW CARTRIDGE WARNINGS IN THE ALARM HISTORY. HE DENIED CHANGE IN ACTIVITY, DIET, MEDICATIONS, OR WEIGHT. THE PT STATED THAT HE WAS ILL FOR FIVE DAYS OUT OF TIME PERIOD IN QUESTION. HE REPORTED THAT THE INFUSION SITES WERE FREE OF SCAR TISSUE, REDNESS, SWELLING, PAIN, OR DISCHARGE; THERE HAVE BEEN NO BENT CANNULAS; HE ROTATES SITES; THERE NO LEAKING AT CARTRIDGE OR SKIN SITES; AND THERE WAS NO AIR IN THE TUBING OR CARTRIDGES WITH LAST TWO SITE CHANGES. THE PT SAID HE FILLS CARTRIDGES WITH COLD INSULIN AND HE REFILLS CARTRIDGES EVERY THREE TO FOUR DAYS. THE PT WAS ADVISED TO USE ROOM TEMPERATURE INSULIN TO AVOID AIR BUBBLE FORMATION AND TO CONSULT HIS HEALTH CARE PROVIDER REGARDING THE POSSIBLE NEED FOR PUMP SETTING ADJUSTMENTS. HE WAS TOLD THAT THERE WAS NO EVIDENCE OF PRODUCT MALFUNCTION OR DEFECT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR