BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2923191 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00892
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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.

    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 INSULIN DELIVERY DEFECT WAS FOUND THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATE. FORCE SENSOR CALIBRATION CHECK SHOWS THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5LBS. FORCE SENSOR RESISTANCE WAS FOUND IN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT ELEVATED BLOOD GLUCOSE (BG) READINGS SINCE THE DAY PRIOR. THE PATIENT REPORTED THAT AT 5:09 PM, SHE OBTAINED A READING OF 341 MG/DL. THE PATIENT STATED SHE TOOK A CORRECTION BOLUS FOR THE ELEVATED BG; HOWEVER, DID NOT BOLUS FOR HER MEAL. AT 9:41 PM, THE PATIENT CLAIMED HER BG WAS UP TO 579 MG/DL WITH SYMPTOMS OF INCREASED THIRST. THE PATIENT REPORTED DRINKING WATER AND TAKING A CORRECTION BOLUS. ON THE MORNING OF (B)(6) 2012 AT 5:10 AM, THE PATIENT OBTAINED A BG READING OF "HI" (BG GREATER THAN 600 MG/DL). THE PATIENT CHANGED OUT HER SIDE AND WHEN SHE RECHECKED HER BG 5 MINUTES LATER IT WAS 594 MG/DL. THE PATIENT TOOK A CORRECTION BOLUS VIA HER METER REMOTE. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT NOTED THAT THE PUMP WAS SET TO THE CORRECT DATE; HOWEVER, THE TIME ON THE PUMP WAS ONE HOUR AHEAD. THE PATIENT CONFIRMED THAT SHE HAD NOT UPDATED THE TIME FOR DAYLIGHTS SAVINGS TIME. THE PATIENT CONFIRMED ALL OTHER PUMP SETTINGS WERE CORRECT. THERE WERE NO PERTINENT ALARMS IN PUMP HISTORY. CUSTOMER SUPPORT NOTED THAT ALL BOLUSES WERE DELIVERED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY. INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE HIGH BLOOD GLUCOSE EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27651 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R