BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132617 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04245
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP # 2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN, UNABLE TO DUPLICATE THE COMPLAINT. A FORCE SENSOR CALIBRATION TEST SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. THE AVAILABLE BLACK BOX AND ALARM HISTORY WERE REVIEWED AND NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 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

    ON (B)(6) 2011 IT WAS REPORTED THAT THE PATIENT HAD OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 400 MG/DL TO 500 MG/DL FOR THREE DAYS, AND HE EXPERIENCED THE SYMPTOM OF LOW BLOOD PRESSURE. THE PATIENT DID NOT TEST FOR KETONES. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PUMP HAD GIVEN OCCLUSION ALARMS AND THE CANNULA WAS BENT WHEN THE INFUSION SET WAS CHANGED. THERE WERE NO ISSUES FOUND WITH THE CARTRIDGE OR INFUSION SITE; ALL PUMP SETTINGS WERE CORRECT, THE DATE/TIME WERE CORRECT, AND ALL BASAL/BOLUS TOTALS CORRECTLY MATCHED THOSE PROGRAMMED. THERE IS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT AS THE INFUSION CANNULA WAS BENT, WHICH CAN LEAD TO UNDER-INFUSION OF INSULIN. HOWEVER, AS THE PATIENT OBTAINED BLOOD GLUCOSE READINGS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, THIS 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 87 YR Life Threatening