BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933010 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01283
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 04/23/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE UP ARROW, DOWN ARROW, AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE; THE OK KEYPAD BUTTON RESPONDED APPROPRIATELY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM/FADED DISPLAY SCREEN. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN WHICH WAS FULLY ILLUMINATED.

    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)(4) 2013 REPORTING THAT FOR THE PAST THREE MONTHS THE UP ARROW WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE PATIENT STATED THAT THE KEYPAD IS INTACT. THE PATIENT REPORTED THAT THERE WERE MULTIPLE BOLUSES ARE AT 0 UNITS IN THE BOLUS HISTORY AND THE PATIENT THOUGHT SHE HAD GIVEN HERSELF BOLUSES BUT ARE RECORDED AS 0 UNITS GIVEN. THE PATIENT STATED THAT HER BLOOD GLUCOSE (BG) WAS ELEVATED IN THE 250'S MG/DL WITH NOT FEELING WELL, SHE FELT TIRED AND HAD A STOMACH ACHE AND HEADACHE AND NOT CHECKED FOR KETONES. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. SHE TREATED HERSELF WITH A BOLUS AND THE BG CAME DOWN. THE PATIENT STATED THAT SHE HAD THE FLU FOR THE LAST COUPLE OF WEEKS TOO. CUSTOMER SUPPORT ASKED THE PATIENT TO SET PUMP FOR SOUND SINCE VIBRATION IS NOT WORKING. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38702 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR