BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190110 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09003
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/16/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS FROM WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LAST BASAL DELIVERY WAS ON (B)(6) 2013 AND THE LAST BOLUS WAS RECORDED ON (B)(6) 2013. A REVIEW OF THE BLACK BOX HISTORY REVEALED THAT THE PUMP WAS NOT IN USE ON (B)(6) 2013 FROM 5:30AM TO 9:12AM. THERE WERE NO ALARMS RELATED TO THE REPORTED COMPLAINT OBSERVED IN THE BLACK BOX OR PUMP ALARM HISTORY; ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) BETWEEN 400 AND 600MG/DL FOR THE PAST THREE DAYS. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTER STATED THAT THE BASAL RATE WAS INCREASED FROM 0.300UNITS/HOUR TO 0.500UNITS/HOUR AND SHE IS WAITING ON A CALL BACK FROM THE PATIENT¿S HEALTHCARE PROVIDER (HCP). THE PATIENT¿S BGS ARE REPORTEDLY TREATED WITH CORRECTION INJECTIONS AND BG WILL RESPOND BUT THEN WILL ELEVATE AGAIN. THE REPORTER DENIED REUSING SUPPLIES AND CONFIRMED THE INSULIN IS NOT EXPIRED. THE REPORTER DENIED ANY BENT CANNULAS. THE REPORTER STATED SUPPLIES ARE CHANGED EVERY THREE DAYS. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND THE TOTAL DAILY DOSE HISTORY ADDS UP CORRECTLY WITH BASAL AND BOLUS HISTORIES AND SETTINGS WERE FOUND TO BE CORRECT. A REVIEW OF THE PRIME HISTORY INDICATED THE TUBING WAS BEING REUSED DUE TO NO PRIME AMOUNTS SHOWING FOR CERTAIN DAYS. THERE WAS ALSO A FIVE DAY GAP WITH NO FILL CANNULA AMOUNTS RECORDED FROM (B)(4) 2013. THE REPORTER WAS A POOR HISTORIAN AND COULD NOT EXPLAIN THE REASONS FOR THIS, BUT DENIED THAT SUPPLIES WERE BEING REUSED. THE REPORTER STATED SUPPLIES WERE CHANGED OUT THE PREVIOUS EVENING, (B)(4) 2013. TROUBLESHOOTING INDICATED NO PUMP MALFUNCTION AND NO ISSUES WITH INSULIN, SUPPLIES, OR SITES. THE REPORTER WAS INSTRUCTED TO DISCUSS POSSIBLE SETTINGS ADJUSTMENTS WITH THE PATIENT¿S HCP, AND WAS ADVISED NOT TO REUSE SUPPLIES AND TO CHANGE SUPPLIES EVERY TWO TO THREE DAYS. A FOLLOW-UP INDICATED THAT THE PATIENT WENT OFF THE PUMP ON (B)(4) 2013 AND WAS ON INJECTIONS AND BGS WERE STABLE. THE PATIENT WAS SENT A LOANER PUMP FROM THE TERRITORY MANAGER AND BGS HAVE BEEN NORMAL USING THE LOANER PUMP. THE CLINICAL MANAGER REQUESTED THE PATIENT¿S PUMP BE REPLACED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY AND BASED ON THE REQUEST FOR THE PUMP TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290451 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening