BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2500057 · Received March 22, 2012

    Report

    Report Number
    2531779-2012-02343
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONAL FINDING SUBMITTED ON (B)(4) 2012 SHOULD HAVE MARKED AS FOLLOW UP #2 INSTEAD OF FOLLOW UP #1 IN THE NARRATIVE.

    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. CORRECTION NUMBER - 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE INSULIN CARTRIDGE HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 - SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED TWO "NO CARTRIDGE DETECTED" WARNINGS AND MULTIPLE "LOSS OF PRIME" WARNINGS. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. ON TESTING, THE PUMP POWERED ON NORMALLY. DURING THE LOAD STEP, THE PUMP APPROPRIATELY RECOGNIZED THE CARTRIDGE AND THE PUMP PRIMED AS INTENDED. THE FORCE SENSOR WAS EVALUATED AND WAS FOUND TO BE OUT OF SPECIFICATION. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS OPENED FOR INVESTIGATION AND THERE WAS CONTAMINATION NOTED ON THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT ON (B)(6) 2012 THE PUMP ALARMED THAT IT WAS NOT PRIMED. THE PATIENT REPORTEDLY DID NOT DISCONNECT FROM THE PUMP AND ATTEMPTED TO PRIME. THE PATIENT INADVERTENTLY CLICKED ON THE LOAD STEP INSTEAD OF THE PRIME STEP. THE PUMP REPORTEDLY BEGAN PUSHING INSULIN INTO THE PATIENT. THE PATIENT REPORTEDLY DISCONNECTED AS QUICKLY AS THEY COULD, HOWEVER THE PATIENT'S BLOOD GLUCOSE DROPPED TO 44 MG/DL AND WAS SHAKY AND SWEATING. THE PATIENT REPORTEDLY WAS ABLE TO EAT AND CORRECT HIS BLOOD GLUCOSE LEVEL TO BETWEEN 80 AND 100MG/DL, THE PATIENT THEN ATE PASTA FOR DINNER AND HAD NO MORE BLOOD GLUCOSE ISSUES. THE PATIENT WAS REPORTEDLY AWARE OF THE LOAD STEP ISSUES AND INDICATED THAT IT HAD OCCURRED ONCE BEFORE WHEN HE WAS NOT CONNECTED TO THE PUMP AND THE PUMP EMITTED A "NO CARTRIDGE DETECTED" WARNING. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING IT. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE PRIME / REWIND SEQUENCE. THIS REPORT IS BEING MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS RELATED TO USE ERROR AND THE PUMP DISPENSING INSULIN DURING THE LOAD CARTRIDGE STEP.

    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 22 YR Life Threatening