BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132814 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04251
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PUMP¿S HISTORY SHOWED THAT THE TOTAL DAILY DOSES WERE INCONGRUENT; THERE WAS NO DATA IN THE HISTORY FROM THE EVENT DATE DUE TO CONTINUED USE. THE DAILY INSULIN DOSES APPEARED TO BE INCONSISTENT DUE TO THE TIME AND DATE ISSUE. THERE WAS NO DATA FROM THE TIME OF THE REPORT INDICATING THAT THERE WERE LOW BGS DUE TO CONTINUED USE OF THE PUMP. DURING TESTING, THE PUMP¿S BATTERY WAS REMOVED FOR SIX HOURS AND WHEN THE PUMP WAS POWERED BACK ON THE TIME AND DATE HAD RESET TO FACTORY DEFAULT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. DURING EVALUATION, THE PUMP¿S INTERNAL BATTERY WAS FOUND TO BE LEAKING.

    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 PATIENT CONTACTED ANIMAS ON (B)(6) 2011 ALLEGING THAT HIS PUMP WAS SET TO THE INCORRECT DATE AND TIME OF (B)(6) 2007. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED ON THE EVENING OF (B)(6) 2011. THE PATIENT CLAIMED JUST PRIOR TO DINNER ON (B)(6) 2011 HE BEGAN TO SWEAT AND FEEL DISORIENTED. WHEN HE TESTED HIS BLOOD GLUCOSE (BG) HE OBTAINED A LOW RESULT OF '37 MG/DL". THE PATIENT REPORTED THAT HE ATE DINNER RIGHT AWAY AND CONFIRMED FEELING BETTER AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THAT THE PUMP STILL HAS ORIGINAL BATTERY CAP FROM 2009; HOWEVER, O-RING NOT VISIBLE. THE PATIENT DENIED ANY POWER LOSS OR DISRUPTION IN POWER TO PUMP. THE PATIENT WAS UNABLE TO CONFIRM HOW LONG THE PUMP WAS SET WITH INCORRECT DATE AND TIME. DURING REVIEW OF PUMP HISTORY, IT WAS NOTED THAT THE PATIENT WAS RECEIVING HIS 1.65 BASAL RATE INSTEAD OF 1.1 UNITS DUE TO INCORRECT SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED REPORTED ISSUE BEGAN.

    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 80 YR Life Threatening| R