BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2222072 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06190
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 10/23/2014 WITH THE FOLLOWING RESULTS: REVIEW OF THE AVAILABLE PUMP HISTORY SHOWS NO ALARMS RELATED TO THE COMPLAINT. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USER PROGRAMMED BASAL RATE. BLACK BOX BEGINS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2011 HAVE BEEN OVERWRITTEN. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AT THREADS AND BETWEEN BUMPER PAD AND COVER: THE RETURNED BATTERY CAP IS ABLE TO ATTACH TO THE PUMP. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. REMOVED COVER; THE FORCE SENSOR RESISTANCE WAS FOUND TO BE OUT SPECIFICATION. NO CONTAMINATION OBSERVED IN FORCE SENOR HOUSING. 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.

    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. THE PATIENT ATTEMPTED TO PROGRAM THE PUMP BY HIMSELF; CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND SEVERAL SETTINGS WERE PROGRAMMED INCORRECTLY. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE EXPERIENCED BLOOD GLUCOSE (BG) LEVELS OF 35 - 45 MG/DL FOR THE LAST THREE NIGHTS. THE PATIENT REPORTED THAT HE TREATED THE LOW BG WITH ORANGE JUICE. THE PATIENT REPORTED THAT HE RECEIVED HIS REPLACEMENT PUMP AND PROGRAMMED IT HIMSELF, BUT THINKS HE MAY HAVE DONE IT INCORRECTLY. CUSTOMER SUPPORT REVIEWED THE PUMP AND ASSISTED THE PATIENT IN CORRECTING THE TIME FROM 4 AM TO 1 PM. CUSTOMER SUPPORT ALSO ASSISTED THE PATIENT WITH CORRECTING THE BASAL RATES TO MATCH HIS OLD PUMP'S SETTINGS AT 12 AM, .65 UNITS/HOUR TO .9 UNITS/HOUR, AND 8 AM, 2.3 UNITS/HOUR TO 1.675 UNITS/HOUR. THE PATIENT CONFIRMED THAT THE OTHER PUMP SETTINGS WERE CORRECT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AFTER PROGRAMMING HIS REPLACEMENT PUMP INCORRECTLY.

    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 72 YR Life Threatening| R