BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2240583 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06670
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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

    THE PATIENT REPORTED THAT ON (B)(6) 2011 HER HUSBAND TOOK HER TO THE HOSPITAL FOR LOW BLOOD GLUCOSE (BG). THE PATIENT STATED THAT SHE HAS A HISTORY OF LOW BGS, AND HAD BEEN RANGING FROM 32MG/DL TO 100MG/DL. THE PATIENT DID NOT KNOW WHAT HER BG WAS AT THE TIME OF THE HOSPITALIZATION, AND DENIED ANY SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT STATED THAT SHE WAS (B)(6) PREGNANT AT THE TIME OF THE INCIDENT, AND SHE HAD A HIGH RISK PREGNANCY AND WAS STRESSED DUE TO THE PREGNANCY. THE PATIENT STATED THAT HER HEALTH CARE PROVIDER NEEDED TO MAKE CHANGES TO HER SETTINGS AND THAT SHE WOULD BE IN THE HOSPITAL UNTIL HER SETTINGS AND BG WERE REGULATED. THE PATIENT REPORTEDLY WAS NOT REMOVED FROM THE PUMP WHILE IN THE HOSPITAL. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND DETERMINED THAT THE PUMP SETTINGS WERE CORRECT. THERE WAS NO INDICATION OF A PUMP MALFUNCTION. CUSTOMER SUPPORT CONCLUDED THAT THE PATIENT'S ERRATIC BGS WERE RELATED TO THE PREGNANCY AND TO THE NEED FOR SETTINGS ADJUSTMENTS. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. DURING A FOLLOW-UP CALL ON (B)(6) 2011, THE PATIENT INDICATED THAT HER BGS HAVE BEEN "GOOD" AND SHE COULD NOT REMEMBER WHAT DATE SHE WAS DISCHARGED FROM THE HOSPITAL. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    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 20 YR Hospitalization| L| R