BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2123339 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04137
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 #2 DATE OF SUBMISSION (B)(6) 2011. 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

    FOLLOW-UP #3 STATED "DATE OF SUBMISSION (B)(4) 2016" IN THE ADDITIONAL MANUFACTURER NARRATIVE, HOWEVER THE ACTUAL DATE OF SUBMISSION WAS (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE PATIENT RELATING TO THE PATIENT'S REPORTED HOSPITALIZATION ON (B)(6) 2011. THE PATIENT STATED THAT SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. SHE CONFIRMED THAT HER DIAGNOSIS WAS DIABETIC KETOACIDOSIS (DKA) AND A URINARY TRACT INFECTION (UTI). CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT TIME AND DATE SETTINGS WERE CORRECT; INSULIN DELIVERY SETTINGS MATCHED THE PUMP'S HISTORY; AND THERE WERE NO RELATED ALARMS NOTED. A REVIEW OF THE PUMP HISTORY INDICATED SMALL PRIME VOLUMES; THE PATIENT REPORTED THAT INSULIN COMES OUT DURING THE LOAD STEP. SHE ALSO NOTED THAT THE BATTERY CAP WAS NOT SECURING TO THE PUMP PROPERLY AND THE PUMP HAD BEEN REBOOTING. DURING THE CALL WITH CS, THE PATIENT WAS SUCCESSFULLY ABLE TO PRIME INTO THE AIR WITH NO REPORTED ISSUES. THE PATIENT STATED THAT THERE WAS NO AIR IN THE CARTRIDGE, THERE WERE NO SITE ISSUES, AND THERE WAS NO LEAKING NOTED AT ANY OF THE CARTRIDGE/TUBING CONNECTIONS. THE PUMP IS NOT BEING RETURNED AT THIS TIME. THE PATIENT STATED THAT SHE HAS CONTINUED USING THE PUMP; THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THE ALLEGATIONS OF THE PUMP REBOOTING AND THE INSULIN BEING DISPENSED DURING THE LOAD STEP HAVE BEEN ADDRESSED THROUGH SEPARATE COMPLAINTS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #3 DATE OF SUBMISSION "(B)(4) 2016" - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS FOR (B)(6) 2011 ARE LOWER THAN THE USER'S PROGRAMMED RATES. MULTIPLE OCCLUSION ALARMS WERE OBSERVED IN THE ALARM HISTORY FOR (B)(4) 2011. THE BLACK BOX DATA FROM THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. NO OCCLUSIONS OCCURRED DURING TESTING. AN OCCLUSION WAS INDUCED DURING INVESTIGATION AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERTS. CORRECTION: THE SERIAL # REPORTED ON THE INITIAL MDR IS (B)(4). THE CORRECT SERIAL # FOR THIS DEVICE IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HIS DAUGHTER (THE PATIENT) AND REPORTED THAT SHE WAS HOSPITALIZED WITH A BLOOD GLUCOSE (BG) LEVEL OF "800 MG/DL" AND SYMPTOMS OF NAUSEA, VOMITING, AND LARGE KETONES. THE PATIENT ALSO REPORTEDLY HAD A URINARY TRACT INFECTION (UTI). (B)(6) PRIOR TO THE HOSPITALIZATION, THE REPORTER CLAIMED THAT THE PATIENT WAS GETTING OCCLUSION ALARMS. A REVIEW OF THE PRIME HISTORY REVEALED THAT THE OCCLUSION ALARMS WERE ASSOCIATED WITH A PRIME AMOUNT. THE REPORTER CONFIRMED THAT THE BASAL RATE AND BOLUS SETTINGS WERE CORRECT. HOWEVER, A REVIEW OF THE PUMP HISTORY REVEALED THAT THE TDD WAS NOT ADDING UP CORRECTLY WITH THE 24 HOUR BASAL TOTAL BECAUSE OF MULTIPLE BREAKS IN INSULIN DELIVERY RELATED TO MULTIPLE OCCLUSION ALARMS. THE REPORTER WAS UNSURE IF THE PATIENT WAS PROPERLY PROGRAMMING THE RECOMMENDED BOLUSES. HE ALSO FELT AS THOUGH THE PATIENT WAS POSSIBLY REUSING HER CARTRIDGE(S) AND USING CLOUDY INSULIN. THE REPORTER MENTIONED THAT HE OBTAINED 2 NEW INSULIN VIALS AND THE PATIENT'S BG HAD COME DOWN OVER THE PREVIOUS 24 HOURS. ACCORDING TO THE REPORTER, ALL THE PATIENT'S SYMPTOMS WERE RESOLVED AND HER ELECTROLYTE IMBALANCE ASSOCIATED WITH DKA WAS SLOWING RESOLVING. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD SCAR TISSUE AND WAS UNSURE IF THE PATIENT WAS ROTATING/CHANGING HER SITES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA. HOWEVER, THE PATIENT'S ELEVATED BG LEVEL CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR SINCE THE PATIENT WAS ALLEGEDLY USING CONTAMINATED INSULIN, RE-USING HER CARTRIDGES, POSSIBLY NOT CHANGING OUT HER SITES AS RECOMMENDED, AND NOT PROGRAMMING THE RECOMMENDED BOLUS AMOUNTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L| R