BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232174 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06426
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN WRITTEN OVER, TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. THE PUMP WAS TESTED ON A 29 HOUR FLOW ACCURACY TEST; THE PUMP PASSED THE ASSESSMENT AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN SPECIFICATION. THE USERS PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THERE ARE NO ERRORS OR ALARMS RELATED TO THE COMPLAINT IN THE EXISTING BLACK BOX OR ALARM HISTORY.

    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 REPORTED THAT HE EXPERIENCED A BLOOD GLUCOSE (BG) OF 463 MG/DL WITH QUEASINESS. THE PATIENT REPORTED THAT PRIOR TO LUNCH, HIS BG WAS 103 MG/DL; HE BOLUSED CORRECTLY WITH LUNCH. HE REPORTED THAT BY 2:54 PM HIS BG WAS 420 MG/DL; HE GAVE A CORRECTION BUT HIS BG AT 4:20 PM WAS 463 MG/DL. THE PATIENT REPORTED THAT THE LAST SITE CHANGE WAS (B)(6). HE WAS UNABLE TO CHANGE THE SITE WHILE ON THE PHONE AS HE DID NOT HAVE SUPPLIES. (B)(4) REVIEWED THE PUMP WITH THE PATIENT AND THE PATIENT CONFIRMED THAT THE HISTORY AND SETTINGS WERE CORRECT. THE PATIENT REPORTED NO CHANGES IN ACTIVITY OR MEDICATIONS. (B)(4) CONCLUDED THAT THERE WAS NO EVIDENCE OF A MECHANICAL ISSUE WITH THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 64 YR Required Intervention