BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2110751 · Received June 1, 2011

    Report

    Report Number
    2531779-2011-03855
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/17/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION RECORDED IN THE BLACK BOX OR ALARM HISTORY. THERE WAS NO DATA AVAILABLE IN THE DOWNLOAD HISTORY OR BLACK BOX FOR THE TIME OF THE REPORTED LOW 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, A DIM/FADED AND SCRATCHED DISPLAY LENS WAS FOUND, WHICH HAS NO EFFECT ON INSULIN DELIVERY.

    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 CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT HE WENT UNCONSCIOUS AFTER HE TOOK BOLUS INSULIN WITH THE ANIMAS PUMP UNINTENTIONALLY WITHOUT CHECKING HIS BLOOD GLUCOSE. THE PATIENT WAS FOUND UNCONSCIOUS 6 HOURS LATER AND WAS TAKEN TO THE HOSPITAL FOR TREATMENT. THE PATIENT INDICATED THAT THE LOW BLOOD GLUCOSE WAS HIS FAULT. HE REPORTEDLY WENT FISHING THE DAY PRIOR TO THE ALLEGED HYPOGLYCEMIA AND DID NOT EAT ALL DAY. THE NEXT DAY HE INADVERTENTLY TOOK BOLUS INSULIN WITHOUT KNOWING HIS BLOOD GLUCOSE AND WENT UNCONSCIOUS. THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH A BLOOD GLUCOSE READING OF "17 MG/DL." DURING HIS HOSPITAL STAY, HIS BLOOD GLUCOSE RANGED FROM 500 MG/DL TO 35 MG/DL. HIS BLOOD GLUCOSE WAS CORRECT VIA SYRINGE AND THE ANIMAS INSULIN PUMP. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONFIRMED THE PUMP WAS WORKING ACCORDINGLY. DURING HIS HOSPITAL STILL, THE PATIENT'S INSULIN REGIMEN WAS UNDER EVALUATION TO BE ADJUSTED ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR HYPOGLYCEMIA WHILE HIS DIABETES WAS MANAGED WITH THE ANIMAS 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 69 YR Hospitalization| L| R