BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161384 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04921
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1, (B)(4) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(4) 2011 TO END OF PUMP USE ON (B)(4) 2011 SHOWED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP BLACKBOX HISTORY INDICATED THERE WAS AN UNCONFIRMED 'EMPTY CARTRIDGE' ALARM ON (B)(6) 2011 AT 19:36. THE PUMP ENTERED REBOOT CYCLE ON (B)(6) 2011 09:45. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE (BG) OF 738 MG/DL, SHORTNESS OF BREATH, NAUSEA, VOMITING, AND WAS HAVING DIFFICULTY WALKING. SHE STATED THE PATIENT RECEIVED A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA), AND WAS REMOVED FROM THE PUMP AND TREATED WITH INTRAVENOUS (IV) INSULIN. THE FAMILY MEMBER REPORTED THAT THE PATIENT WAS REMOVED FROM THE IV INSULIN ON (B)(6) 2011 AND STARTED ON INJECTION THERAPY; SHE STATED THAT THE PATIENT'S BG HAD RESOLVED TO 180 MG/DL ON INJECTIONS. THE PATIENT REPORTED THAT HER BLOOD-WORK CAME BACK NORMAL; THERE WERE NO SIGNS OF INFECTION OR ILLNESS. AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT (CS), THE FAMILY MEMBER REINSERTED THE PUMP'S BATTERY FOR TROUBLESHOOTING AND NOTED THAT THE TIME WAS OFF BY AN HOUR; SHE STATED THAT IT WAS POSSIBLE THE TIME WAS NEVER ADJUSTED FOR DAYLIGHT SAVINGS. A REVIEW OF THE PUMP HISTORY FOR (B)(6) 2011 AND (B)(6) 2011 INDICATED THAT THE BASAL AND BOLUS HISTORIES MATCHED THE TOTAL DAILY DOSE HISTORY. THE PATIENT CONFIRMED THAT HER BASAL RATE AND INSULIN TO CARBOHYDRATE RATIO SETTINGS WERE CORRECT, BUT WAS UNSURE OF OTHER PUMP SETTINGS. A REVIEW OF THE PUMP'S ALARM HISTORY INDICATED THAT THE PATIENT PERFORMED A ROUTINE CARTRIDGE/SITE/SET CHANGE ON (B)(6) 2011. THE PATIENT STATED THAT SHE LAST TESTED HER BG ON (B)(6) 2011 AND IT WAS 180 MG/DL, AND HER BGS BEGAN ELEVATING ON (B)(6) 2011 AFTER LUNCH. THE PATIENT REPORTED THAT SHE BOLUSED TWICE FOR FOOD INTAKE ON (B)(6) 2011, BUT DID NOT CHECK HER BG THAT DAY. SHE STATED THAT SHE DID NOT HAVE ANYTHING ELSE TO EAT ON (B)(6) 2011 AFTER LUNCH. THE PATIENT REPORTEDLY BEGAN "NOT FEELING WELL" THE AFTERNOON OF (B)(6) 2011, AND PERFORMED ANOTHER SITE/SET CHANGE. SHE STATED THAT THE CANNULA ON THE PREVIOUS SET WAS NOT BENT, AND THERE WERE NO SITE ISSUES. THE PATIENT REPORTEDLY WAS USING THE UPPER AND LOWER ABDOMEN ONLY FOR SITES. THE PUMP HISTORY INDICATED THAT THE PATIENT DELIVERED MULTIPLE CORRECTION BOLUSES THROUGHOUT THE NIGHT. THE PATIENT REPORTED THAT SHE EXPERIENCED NAUSEA, VOMITING, DIARRHEA, AND WEAKNESS THROUGH THE NIGHT, AND WAS TAKEN TO THE ER THE MORNING OF (B)(6) 2011. THE FAMILY MEMBER STATED THAT THE SITE/SET WAS REMOVED AT THE HOSPITAL, AND THE CANNULA WAS NOT BENT AND THERE WERE NO SITE ISSUES. THE FAMILY MEMBER STATED THAT THERE WERE NO ISSUES NOTED WITH THE INSULIN. THE PATIENT'S PRIMARY CARE DOCTOR REPORTEDLY DID NOT WANT THE PATIENT TO RESUME INSULIN PUMP THERAPY, AS HE STATED THAT THE PATIENT'S BGS WERE NOT WELL CONTROLLED FOR (B)(6) PRIOR TO THE INCIDENT. TROUBLESHOOTING INDICATED THAT THE PUMP WAS FUNCTIONING APPROPRIATELY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED DKA WHILE USING INSULIN PUMP THERAPY. USE ERROR CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE REPORTED INCIDENT, AS THE PATIENT HAD REPORTEDLY BEEN EXPERIENCING ERRATIC BGS A MONTH PRIOR TO THE INCIDENT, AND WAS NOT CHECKING BGS APPROPRIATELY THE DAY PRIOR TO THE INCIDENT.

    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 79 YR Hospitalization