BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2971422 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-01971
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 05/17/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS THE LAST BASAL DELIVERY AND THE LAST BOLUS OCCURRED ON (B)(6) 2013. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT OBSERVED IN THE BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE REPORTER (PATIENT'S FATHER) CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PATIENT'S BLOOD GLUCOSE (BG) HAD BEEN ELEVATED OVER THE PRIOR FOUR DAYS AND HAD ELEVATED TO 588 MG/DL AFTER LUNCH THE DAY OF THE CALL. THE REPORTER STATED THAT THE PATIENT WAS TREATED FOR THE ELEVATED BG WITH AN INSULIN INJECTION, WHICH BROUGHT THE BG DOWN TO 136 MG/DL AND THE PATIENT WAS RESTARTED ON INSULIN PUMP THERAPY (IPT). THE REPORTER STATED THAT AFTER RESUMING IPT, THE PATIENT'S BG ELEVATED AGAIN TO THE 300 MG/DL RANGE. THE REPORTER STATED THE PATIENT WAS DISCONTINUED FOR IPT AGAIN AND IS ON A BACK-UP PLAN FOR INSULIN DELIVERY AT THE TIME OF THE CALL. THE REPORTER ALLEGED THE INSULIN PUMP WAS NOT DELIVERING INSULIN AND INSISTED ON THE PUMP BEING REPLACED. THE REPORTER CONFIRMED WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) THAT THERE WERE NO PUMP ALARMS, BUT DECLINED TO CHECK THE PUMP HISTORY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG WHILE ON IPT USING A PUMP WITH AN ALLEGED DELIVERY ISSUE THAT WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76618 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention