BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2102226 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03683
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED MULTIPLE LOSS OF PRIME WARNINGS AND OCCLUSION ALARMS HAD OCCURRED, WHICH COULD NOT BE DUPLICATED DURING TESTING. THERE WAS NO EVIDENCE IN THE PUMP HISTORY THAT "NO CARTRIDGE DETECTED" WARNINGS HAD OCCURRED. AN EZPRIME OPERATION WAS PERFORMED DURING TESTING WITH NO ISSUES; THE PUMP RECOGNIZED THE CARTRIDGE DURING THE "LOAD" STEP, AND DID NOT PUSH INSULIN OUT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES AND NO ALARMS OCCURRING. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT HAD A BLOOD GLUCOSE OF HI ALL DAY (ABOVE 600 MG/DL) WITH KETONES. PATIENT DISCONTINUED USE OF THE PUMP AND IS ON AN ALTERNATIVE TREATMENT PLAN. SHE REPORTS THAT PATIENT RECEIVED SEVERAL OCCLUSION ALARMS TODAY DURING BOLUS DELIVERY AND IS UNSURE IF THE PUMP DELIVERED FULL BOLUS. SHE STATED THAT THE PUMP HISTORY SHOWED SIX OCCLUSION ALARMS. SHE CONFIRMED THAT THERE WERE NO ISSUES WITH THE SITE. SHE REPORTED THAT THE TUBING WAS CHANGED THREE TIMES AND INFUSION SET WAS ALSO REPLACED THREE TIMES; NO BENT OR KINKED CANNULA WERE SEEN. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER HAVING MULTIPLE, IRRESOLVABLE OCCLUSION ALARMS.

    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 14 YR