BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2220553 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06119
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT WAS TAKEN TO HOSPITAL ON (B)(6) 2011 JUST STARTING DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE (BG) OF 377 MG/DL; THE PATIENT WAS WEARING THE PUMP UPON ADMISSION. THE PUMP WAS REMOVED AND PT WAS TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE PUMP WITH A BG OF 125 MG/DL; HOWEVER THE PATIENT WAS STILL USING SAME CARTRIDGE AND INFUSION SET. THE PATIENT'S BG REPORTEDLY ROSE UP TO 405 MG/DL. THE FAMILY MEMBER REPORTED THAT SHE NOTICED THAT THE INFUSION SET WAS COMING OFF AND MOM SAID THERE APPEARED TO BE PUS ON THE CANNULA AND A KNOT AT THE SITE. SHE REPORTED THAT THE PATIENT HAD BEEN WEARING INFUSION SETS IN HIS ABDOMEN AND ALWAYS HAD PUS WITH SITES IN ABDOMEN. THE FAMILY MEMBER STATED THAT PER THE PUMP HISTORY SON DID HAVE AN OCCLUSION ALARM ON (B)(6) 2011; THE PRIME HISTORY INDICATED THAT AFTER THE OCCLUSION ALARM THE PUMP WAS PRIMED SIX TIMES. THE FAMILY MEMBER REPORTED THAT THE PUMP WAS PRIMED DUE TO NOT SEEING DROPS AT THE END OF THE TUBING. THE FAMILY MEMBER REVIEWED THE PUMP PRIME HISTORY BACK TO (B)(6) 2011 AND IT INDICATED THAT THERE WAS NO FILL CANNULA AMOUNTS. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER THAT PER THE PUMP HISTORY, THE PATIENT WAS NOT DOING THE FILL CANNULA STEP. THE FAMILY MEMBER STATED THAT THE EMERGENCY ROOM DOCTOR SAID THAT HE DID NOT THINK THE PUMP WAS WORKING. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER THAT AFTER TROUBLESHOOTING THE PUMP APPEARED TO BE DELIVERING CORRECTLY. THE FAMILY MEMBER REPORTED THAT THE PATIENT WAS USING INSULIN FROM SAME VIAL USED AT THE TIME OF HOSPITALIZATION AND BGS WERE FINE. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER ON CHANGING THE SITE WITH BG ELEVATIONS AND TO CONTACT THE PATIENT'S HEALTH CARE PROVIDER IF THE SITE LOOKS INFECTED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS WHILE USING INSULIN PUMP THERAPY.

    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 10 YR