BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1944387 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03117
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH TROUBLESHOOTING, THE ANIMAS REP INFORMED THE REPORTER THAT THERE WAS NOTHING TO INDICATE THAT THERE WAS A MECHANICAL PROBLEM WITH PUMP. THE ANIMAS REP INFORMED THE REPORTER THAT SINCE THE SKIN SITE WAS RED, THE SITE MIGHT NOT HAVE BEEN GOOD. THE REPORTER ALSO INSTRUCTED THE REPORTER TO MONITOR THE BOLUS DOSES CLOSELY AND CONFIRM THEM IN PUMP'S BOLUS HISTORY. THE ANIMAS REP REVIEWED TIPS FOR PREVENTING BUBBLE FORMATION AND INSTRUCTED THE REPORTER TO MONITOR BLOOD GLUCOSE LEVELS CLOSELY AND TO CALL HCP IF SYMPTOMS WERE NOT RESOLVED OR IF THE BLOOD GLUCOSE DID NOT CONTINUE TO DECREASE.

    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) 2011 WITH THE FOLLOWING FINDINGS: TOTAL DAILY DOSE HISTORY WAS REVIEWED FROM (B)(6) 2011 TO END OF PUMP USE ON (B)(6) 2011. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD. THERE WAS NO EVIDENCE OF DAMAGE TO MOTOR FLEX/CONNECTOR OBSERVED WHEN THE PUMP COVER WAS REMOVED. THE ALARM HISTORY SHOWS SEVERAL CALL SERVICE ALARMS NOTED AS (B)(4) DURING THE PUMP'S REWINDING ACTION. PRODUCT INVESTIGATION WAS UNABLE TO REPRODUCE THE FAILURE. IN CONCLUSION, THERE WAS NO DELIVERY RELATED MALFUNCTION OR CALL SERVICE ALARM ISSUE OBSERVED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6), 2010, ALLEGING ELEVATED BLOOD GLUCOSE LEVELS. HE CONTACTED ANIMAS ON BEHALF OF HIS DAUGHTER (THE PT). THE REPORTER CLAIMED THAT THE PT'S BLOOD GLUCOSE (BG) LEVEL HAD REACHED "570 MG/DL". THE PT ALSO CLAIMED THAT THE PT HAD TRACE KETONES AND NAUSEA. THE REPORTER ALSO CLAIMED THAT THE PT'S BG LEVEL WAS IN THE "400'S" EARLIER IN THE DAY. HE ALSO CLAIMED THAT THE PT HAD CHANGED THE SITE AND SET AT AN UNSPECIFIED TIME. THE REPORTER CLAIMED THAT A CORRECTION DOSE WAS GIVEN AT 9:30 PM BUT THE PT'S BG LEVEL HAD GOTTEN HIGHER SINCE THEN. THE PT REPORTEDLY DISCONNECTED FROM THE PUMP AND TOOK 10 UNITS OF APIDRA VIA SYRINGE. THE REPORTER INDICATED THAT THE PT'S SKIN SITE WAS CHANGED BUT APPEARED TO BE RED. THE REPORTER DENIED THAT THERE WAS SCAR TISSUE. THE PT MENTIONED THAT TUBING HAD MULTIPLE SMALL AIR BUBBLES. THE REPORTER PRIMED THE TUBING AND WAS ABLE TO REMOVE THE AIR BUBBLES. THE REPORTER DENIED ANY LEAKAGE OF THE TUBING, CARTRIDGE CAP, OR LEUR LOCK. THE PUMP'S DATE/TIME WAS REPORTEDLY CORRECT. THE BOLUS HISTORY REVEALED THAT THE CORRECTION DOSE OF 9.25 UNITS WAS CANCELLED AND NOT DELIVERED. THROUGH TROUBLESHOOTING, THE REPORTER WAS ABLE TO ENTER A 1 UNIT BOLUS AND CONFIRM THE ENTRY WAS COMPLETED IN THE BOLUS HISTORY. ALL OTHER BOLUSES IN THE HISTORY WERE CORRECTLY DELIVERED THAT DAY. THE PUMP'S BASAL RATE, ISF, TARGETS, I:C RATIO, IOB, AND TDD WERE REPORTEDLY CORRECT. THE REPORTER DENIED THAT THERE WERE ANY CHANGES WITH THE PT'S DIET AND ACTIVITY. HE ALSO DENIED THAT THE PT HAD AN ILLNESS OR WAS ON ANY NEW MEDICATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT HAD A BG LEVEL AND SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening