BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982595 · Received January 12, 2011

    Report

    Report Number
    2531779-2011-00186
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 14, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP'S DATE/ TIME WERE SET AT THE TIME OF INVESTIGATION AND A 10 UNIT BOLUS WAS PROGRAMMED AND DELIVERED. THE BOLUS WAS PROPERLY RECORDED IN THE HISTORY AND TDD WITH ACCURATE TOTALS. THE BLACK BOX DOWNLOAD CONFIRMED THAT THE USER INITIATED A POWER ON RESET ON (B)(6) 2010 AT 9:32 PM TO CLEAR AN EXCEEDS TDD WARNING. THE PUMP REPORTEDLY DEFAULTED TO THE MANUFACTURING DATE/TIME OF (B)(6) 2007, 12:00 AM. THE BLACK BOX CONFIRMED THAT THE USER RESET THE TIME TO 10:40 AM INSTEAD OF PM AFTER THE PUMP TIME WAS DEFAULTED. DUE TO THE INCORRECT TIME SET AFTER THE PUMP DEFAULTED, THE PUMP REPORTEDLY RECORDED 35 HOURS OF DELIVERIES FOR (B)(6) 2010 WHICH CAUSED THE PUMP HISTORY TO APPEAR INACCURATE. A POWER ON RESET WAS INITIATED DURING INVESTIGATION AND THE PUMP REPORTEDLY DEFAULTED TO THE MANUFACTURING DATE/TIME. THE PUMP WAS OPENED AND COMPONENT BT1 WAS FOUND TO BE LEAKING AND UNABLE TO HOLD A CHARGE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS DISPLAYING WARNING REGARDING "MAX LIMITS EXCEEDED." A REVIEW OF THE BOLUS HISTORY REVEALED SEVERAL BOLUSES FOR (B)(6) 2010, WHICH WERE REPORTEDLY IN THE WRONG ORDER/TIME. A REVIEW OF THE TDD FOR THAT SAME DAY INDICATED THAT THE BASAL WAS MORE THAN IT SHOULD HAVE BEEN. ALSO, FOR (B)(6) 2010, THE BOLUSES WERE ALLEGEDLY SKIPPED DURING THE AFTERNOON TIME. THE PATIENT INDICATED THAT HE HAD CHANGED THE DATE/TIME OF THE PUMP ON THE MORNING OF (B)(6) 2010, SINCE THE BATTERY CAP ALLEGEDLY BECAME LOOSE. THE BOLUS AND TDD HISTORIES DID NOT APPEAR TO BE ACCURATE BASED ON THE DATE/TIME OF THE PUMP. THE PATIENT WAS INSTRUCTED TO GO TO A BACKUP PLAN FOR INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP'S BOLUS/TDD HISTORIES WERE INACCURATE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1