BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2800488 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12607
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM THE TIME OF THE REPORTED EVENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. MULTIPLE OCCLUSION ALARMS WERE OBSERVED IN THE ALARM HISTORY. THE PUMP HISTORY SHOWS THAT THE TOTAL DAILY DOSE DID NOT REACH THE USER]S PROGRAMMED TOTAL BASAL RATES ON THE REPORTED EVENT DATE DUE TO OCCLUSION ALARMS WHICH INTERRUPTED BASAL DELIVERY. THE PUMP POWERS ON SUCCESSFULLY, BUT THE KEYPAD WAS INITIALLY UNRESPONSIVE. THE KEYPAD ISSUE WAS FIXED SO THAT TESTING COULD BE COMPLETED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. FLOW ACCURACY TESTING WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERY WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER FRIEND (THE PATIENT) AND REPORTED A LOW BLOOD GLUCOSE (BG) EVENT. THE REPORTER INDICATED THAT THE PATIENT HAD BEEN GETTING FREQUENT/PERSISTENT OCCLUSIONS. THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT NOTED THAT THE PATIENT SUFFERED A LOW BG LEVEL OF "40 MG/DL" AS A RESULT OF MULTIPLE ATTEMPTED BOLUSES WITH EACH OCCLUSION. THE PATIENT WAS TREATED ORALLY AND HER BG REPORTEDLY INCREASED TO "168 MG/DL." THE REPORTER ALSO REPORTED THAT AN AIR BUBBLE WAS FOUND IN THE TUBING. IN ADDITION, SHE ALLEGED THAT THE TUBING WAS BROKEN WHICH RESULTED WITH AN INSULIN LEAKAGE. THE REPORTER ALSO ADMITTED THAT WITH THE LAST SITE CHANGE, THE CANNULA WAS FOUND TO HAVE BEEN BENT. THE OCCLUSIONS WERE REPORTEDLY OCCURRING DURING BOLUSES. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT SUFFERED A LOW BG LEVEL SUGGESTIVE OF SEVERE HYPOGLYCEMIA. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR CONSIDERING THE PATIENT ATTEMPTED TO BOLUS MULTIPLE TIMES WITH EACH OCCLUSION THAT REPORTEDLY OCCURRED.

    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 40 YR Life Threatening| R