BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180353 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05306
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE PATIENT REPORTEDLY MAY NOT HAVE PROPERLY PRIMED THE PUMP WHICH MAY HAVE AFFECTED INSULIN DELIVERY AMOUNTS. THE PATIENT ALSO REPORTEDLY DID NOT SET THE TIME ON THE PUMP CORRECTLY, WHICH CAN ALSO AFFECT THE AMOUNT OF INSULIN DELIVERED AT A PARTICULAR TIME. ALTHOUGH THERE IS NO EVIDENCE OF A MALFUNCTION OF THE DEVICE USE ERROR MAY HAVE CONTRIBUTED TO THE PATIENT'S INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE DATE OF THE REPORTED INCIDENT WAS (B)(6) 2011. THE DATA FROM THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2012 TO THE END OF PUMP USE ON (B)(64) 2012 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY ADMITTED INTO AN ICU AT THE HOSPITAL THE EVENING OF (B)(6) 2011 WITH A BLOOD GLUCOSE LEVEL OF "HIGH". THE PATIENT WAS VOMITING AND HAD BLURRED VISION. HE WAS TAKEN OFF THE PUMP BETWEEN 8:30 PM AND MIDNIGHT AND PLACED ON AN IV INSULIN DRIP. THE PATIENT REPORTEDLY WAS PLACED BACK ON INSULIN PUMP THERAPY WITH THE IV DRIP AFTER MIDNIGHT. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE NEXT DAY. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 322 MG/DL THE MORNING SHE CALLED ANIMAS AND AFTER SHE DELIVERED A BOLUS DOSE HER BLOOD GLUCOSE LEVEL DECREASED TO 245 MG/DL. SHE MENTIONED THAT HER (B)(6) HAS CHANGED FROM THE AFTERNOON TO THE MORNING. DURING TROUBLESHOOTING THE PATIENT CONFIRMED THAT THE PUMP INSULIN DELIVERY SETTINGS WERE PROGRAMMED CORRECTLY. ALL BASAL AND BOLUS DOSES WERE DELIVERED AS PROGRAMMED AND CONFIRMED IN THE PUMP HISTORY FOR (B)(6) 2011. THE PRIME HISTORY SHOWS THAT THE PUMP MAY NOT BE COMPLETELY PRIMED DURING INFUSION SET CHANGES AND SOMETIMES THE FILL CANNULA STEP IS OMITTED. THE TIME ON THE PUMP CLOCK WAS SET FOR ONE HOUR EARLIER THAN THE ACTUAL TIME. THE ANIMAS REPRESENTATIVE REVIEWED PROPER PRIMING AMOUNTS FOR NEW TUBING AND THE NEED TO FILL THE CANNULA WITH NEW SITE INSERTIONS. THE REPRESENTATIVE ALSO RECOMMENDED CONSULTING WITH AN HCP FOR POSSIBLE CHANGES IN BLOOD GLUCOSE MANAGEMENT AS THE PATIENT IS NEW ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L| R