BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882654 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14960
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 27, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS NO ACTIVITY OUTSIDE NORMAL USE. THE LAST BASAL DELIVERY WAS ON (B)(4) 2012 AT 4:02PM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES AND NO ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS OPENED FOR INVESTIGATION AND THERE WERE NO DEFECTS FOUND TO THE POWER FLEX OR THE FORCE SENSOR. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6)2012 THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2012 AT 4:30 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 600 MG/DL AND SHE EXPERIENCED THE SYMPTOMS OF HEADACHE AND NAUSEA. THE PATIENT HAD REPLACED THE INFUSION SET ON THAT DAY AT 12:00 PM. THE PATIENT REPORTED SHE TOOK MULTIPLE CORRECTING BOLUS DOSES OF INSULIN VIA THE PUMP, AND HER SUBSEQUENT BLOOD GLUCOSE READINGS WERE 432 MG/DL AND 200 MG/DL. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT WAS NOT PRIMING THE NEW INFUSION SET TUBING WITH SUFFICIENT INSULIN, WHICH CAN CAUSE UNDER-INFUSION OF INSULIN. ALL PUMP SETTINGS, PROGRAMMING, BASAL RATE AND DATE/TIME WERE FOUND TO BE CORRECT, AND ALL TOTAL BASAL/BOLUS DOSES GIVEN CORRECTLY MATCHED THOSE PROGRAMMED; AND THERE WERE NO ISSUES WITH THE INFUSION SET OR INFUSION SITE. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN AS PROGRAMMED. THE PATIENT'S TECHNIQUE WAS INCORRECT BY UNDER-PRIMING THE INFUSION SET TUBING. HOWEVER, AS THE PATIENT SUFFERED BLOOD GLUCOSE LEVELS AND SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER THIS OCCURRED, THE COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening