BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2132976 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04254
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION REVEALED THAT THERE WAS NO DATA AVAILABLE IN THE DOWNLOAD HISTORY OR BLACK BOX FOR THE TIME OF THE REPORTED HIGH BLOOD GLUCOSE LEVELS DUE TO CONTINUED PATIENT USE. THE TOTAL DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE KEYPAD SYMBOLS WERE FOUND TO BE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS REQUESTING ASSISTANCE WITH RECONNECTING TO THE SUBJECT PUMP. THE PATIENT REPORTED THAT THE SITE CAME OUT WHEN HE WENT TO BED ON THE EVENING OF (B)(6) 2011 AND WAS "TOO TIRED" TO PUT A NEW SITE BACK IN AT THE TIME IT OCCURRED AND HAD ATTEMPTED FOR SEVERAL HOURS ON THE MORNING OF (B)(6) 2011 WITH NO SUCCESS. AT THE TIME OF THE CALL, THE PATIENT ALSO REPORTED THAT THE BATTERY DID NOT FIT INTO THE PUMP AND THE PISTON ROD WOULD NOT REWIND ALL THE WAY. THE ANIMAS REPRESENTATIVE WHO ASSISTED THE PATIENT NOTED THAT THE PATIENT WAS CONFUSED, AGITATED AND ANGRY AT THE TIME OF THE CALL. THE PATIENT DENIED HAVING SYMPTOMS OF NAUSEA, VOMITING, SHORTNESS OF BREATH, CHEST PAIN, OR ABDOMINAL PAIN. HOWEVER, THE PATIENT DID COMPLAIN OF FREQUENT URINATION. THE PATIENT STATED HE HAD NOT CHECKED HIS BLOOD GLUCOSE THAT MORNING. AT THE TIME OF TROUBLESHOOTING, THE ANIMAS REP NOTED THAT THE PATIENT WAS ATTEMPTING TO INSERT THE BATTERY INTO THE PUMP'S CARTRIDGE COMPARTMENT. THE PATIENT WAS WALKED THROUGH PROPERLY INSERTING THE BATTERY. THE PATIENT CONFIRMED THE TIME/DATE ON THE PUMP AND WAS ABLE TO FOLLOW DIRECTIONS THROUGH THE EZPRIME STEPS AND WAS SUCCESSFULLY ABLE TO PRIME THE PUMP. WHEN ASKED TO TEST HIS BLOOD GLUCOSE, THE PATIENT REPORTED THAT HE WAS HAVING DIFFICULTY TESTING BG DUE TO HAVING TWO VIALS OF STRIPS WITH DIFFERENT CODES AND HE WAS CONFUSED AND NOT THINKING CLEARLY ON HOW TO TEST BG. THE PATIENT WAS ASKED TO DISCONNECT FROM THE PUMP. THE PATIENT REQUESTED HE BE CALLED BACK TO CONTINUE TROUBLESHOOTING. THE ANIMAS REP NOTED A CALL WAS PLACED SO A PARAMEDIC COULD BE SENT OUT TO DO A 'WELL CHECK". ON (B)(6) 2011, DURING A FOLLOW-UP CALL, THE ANIMAS REP SPOKE WITH THE PATIENT'S SPOUSE. THE PATIENT'S SPOUSE CONFIRMED PARAMEDICS ARRIVED TO THE PATIENT'S HOME ON (B)(6) 2011; HOWEVER, THE PATIENT REFUSED TRANSPORT. ON THE MORNING OF (B)(6) 2011, THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT WENT INTO A "COMA" AND WAS HOSPITALIZED. THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT'S BLOOD GLUCOSE WAS <20MG/DL WHEN CHECKED WITH PARAMEDIC'S METER. IT IS NOT KNOWN WHAT TREATMENT THE PATIENT RECEIVED BY EMS OR WHILE HOSPITALIZED. THE PATIENT'S SPOUSE INFORMED THE ANIMAS REP THAT THE PATIENT BEGAN HAVING ISSUES WITH HIS BLOOD GLUCOSE SINCE HE STARTED A NEW "(B)(6)" DRUG (NAME OF DRUG UNKNOWN) THAT IS KNOWN TO CAUSE BLOOD GLUCOSE PROBLEMS. THE PATIENT WAS REPORTEDLY TAKEN OFF OF THE (B)(6) WHEN HE WAS HOSPITALIZED. THE PATIENT'S WIFE WAS UNABLE TO LOCATE THE PATIENT'S BLOOD GLUCOSE MONITOR TO CONFIRM BLOOD GLUCOSE VALUES PRIOR TO WHEN THE INCIDENT OCCURRED. IN ADDITION, THE SUBJECT METER WAS UNABLE TO BE REVIEWED AT THE TIME OF THE FOLLOW-UP CALL. THE PATIENT'S SPOUSE MENTIONED THAT THE PATIENT'S PHYSICIAN TOLD HER THAT THE PATIENT HAD BEEN HAVING ISSUES WITH SITES; HOWEVER, SHE IS UNAWARE OF WHAT TYPE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER BECOMING DISCONNECTED FROM THE PUMP.

    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 53 YR Hospitalization| L| R