BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213129 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05932
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REVIEW OF THE PUMP HISTORY REVEALED 9 BOLUS DOSES GIVEN WITHIN A 9-MINUTE PERIOD OF TIME THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S LOW BLOOD GLUCOSE EVENT. THERE WAS NO EVIDENCE OF ANY DEVICE MALFUNCTION. THE ANIMAS REPRESENTATIVE RECOMMENDED THAT ADVANCED BOLUS FEATURES BE REVIEWED WITH A HEALTH CARE PROVIDER.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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. 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

    THE PATIENT'S WIFE STATED THAT THE PATIENT'S BLOOD GLUCOSE FELL TO 20 MG/DL AND THAT THE PATIENT LOST CONSCIOUSNESS. REVIEW OF THE PUMP HISTORY REVEALED THAT THE TOTAL DAILY DOSE FOR THE DAY HE LOST CONSCIOUSNESS WAS 60 UNITS. THE PATIENT AVERAGES BETWEEN 30 AND 35 UNITS OF INSULIN DELIVERED PER DAY. REVIEW OF THE BOLUS HISTORY REVEALED 9 BOLUS DOSES OF 4 UNITS EACH PROGRAMMED WITH THE NORMAL BOLUS FEATURE BETWEEN 12:33 AND 12:42 PM. THE PARAMEDICS WERE CALLED AND GLUCAGON WAS ADMINISTERED TO CORRECT THE LOW BLOOD GLUCOSE LEVEL. THE PATIENT'S BLOOD GLUCOSE LEVEL INCREASED TO 167 MG/DL. THE PATIENT REPORTEDLY HAD SOMETHING TO EAT AFTERWARD ALTHOUGH THE WIFE DID NOT SPECIFY WHAT HE HAD TO EAT. WHEN THE PARAMEDICS LEFT HIS BLOOD GLUCOSE LEVEL WAS REPORTEDLY 122 MG/DL. HIS BLOOD GLUCOSE LEVEL BEFORE DINNER WAS 70 MG/DL WITHOUT ANY SYMPTOMS.

    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 70 YR