BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2801622 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12646
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    FOLLOW-UP #1 DATE OF SUBMISSION 12/19//2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR PUMP HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REVIEW OF THE BLACK BOX AND BOLUS HISTORY SHOWS A 3.85 UNIT BOLUS ON (B)(6) 2012 AT 5:15PM AND 1.10 UNIT BOLUS ON (B)(6) 2012 AT 6:50PM. NO BOLUSES WERE PROGRAMMED OR DELIVERED BETWEEN (B)(6) 2012 AND (B)(6) 2012, ONLY BASAL DELIVERIES WERE RECORDED IN THE BLACK BOX DURING THE REPORTED EVENT DATE. THERE WERE NO PUMP CONDITIONS OR ALARMS NOTED IN PUMP ALARM HISTORY OR BLACK BOX TO INDICATE A PUMP MALFUNCTION. A 10 UNIT AUDIO BOLUS AND A NORMAL 10 UNIT BOLUS WERE COMPLETED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS TESTED AND ALL KEYS WERE RESPONSIVE. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. THE REPORTED COMPLAINT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING THAT THE SUBJECT PUMP HISTORY WAS INACCURATE. THE REPORTER CLAIMED THERE WERE MISSING BOLUSES FOR MANY DAYS. THE PATIENT'S MOTHER STATED THAT THE PATIENT BOLUSES 3 TIMES A DAY EVERYDAY; HOWEVER, THE PUMP'S BOLUS HISTORY SHOWED THAT THE LAST BOLUS WAS ADMINISTERED ON (B)(6) 2012. AT THE TIME OF THE CALL, THE REPORTER STATED THAT THE PATIENT BOLUSED ON (B)(6) 2012; HOWEVER, UPON REVIEWING THE PUMP'S BOLUS HISTORY IT DID NOT REFLECT ANY BOLUSES. THE REPORTER ALSO INFORMED CUSTOMER SUPPORT THAT THE PATIENT USES THE PUMP TO DELIVER BOLUSES THE MAJORITY OF THE TIME AND NOT HER METER REMOTE. THE REPORTER ALSO CLAIMED THAT SOME OF THE BOLUSES IN THE HISTORY SHOWED TO BE ADMINISTERED FOUR TIMES OF THE DAY THE PATIENT WOULD NOT BE DELIVERING A BOLUS AS SHE WOULD BE IN CLASS AT SCHOOL AND SHE HAD TO GO TO SCHOOL NURSE IN ORDER TO ADMINISTER ONE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    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 11 YR