BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2992596 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02468
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/02/2013 WITH THE FOLLOWING FINDINGS: THE HISTORY FOR THE DATE OF THE EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUOUS USE OF THE PUMP. ON (B)(4) 2013 AN "EXCEEDS 2 HOUR MAX DAILY LIMIT" WARNING WAS RECORDED. A 12.65U BOLUS WAS DELIVERED IMMEDIATELY AFTER THE WARNING. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES AND ONLY TYPICAL USAGE WAS OBSERVED IN THE BLACK BOX AND ALARMS HISTORY. DURING TESTING, A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND WERE ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO HYPERSENSITIVE KEYPAD BUTTONS WERE OBSERVED. THE COMPLAINT COULD NOT BE DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 DATE OF SUBMISSION (B)(4) 2013 CORRECTION:CORRECTION TO INVESTIGATION RESULTS BY PRODUCT ANALYSIS:THE CORRECT DATE FOR THE REPORTED EVENT IS (B)(4) 2013. THE BLACK BOX DATA FOR THE EVENT ON (B)(4) 2013 HAD BEEN OVERWRITTEN. THE BOLUS HISTORY SHOWED NO EVIDENCE TO SUPPORT THE COMPLAINT OF AN ¿EXCEEDS MAX TDD¿ WARNING. THE HISTORY SHOWED THE LAST BOLUS PERFORMED ON (B)(4) 2013 WAS AT 23:10. THE TOTAL DAILY DOSE OF INSULIN DELIVERIES ADDED UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. ONLY TYPICAL USAGE WAS OBSERVED IN THE BLACK BOX AND ALARMS HISTORY; THERE WERE NO ALARMS RELATED TO THE COMPLAINT. A 10 UNIT NORMAL AND AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE COMPLAINT WAS NOT DUPLICATED DURING THE INVESTIGATION.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PATIENT TRIED TO GIVE A BOLUS IF INSULIN FOR A BLOOD GLUCOSE (BG) OF 483 MG/DL AND THE PUMP ALARMED STATING EXCEEDED TOTALLY DAILY DOSE. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF THE CALL. THIS REPORT IS BEING MADE DUE TO THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97964 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR