BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2193537 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05645
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. NO DATA IN BLACK BOX OR PUMP HISTORIES FROM TIME OF REPORTED ISSUE DUE TO CONTINUED USE. THERE ARE NO ALARMS RELATED TO THE COMPLAINT; OCCLUSION ALARMS NOT OBSERVED IN THE PUMP HISTORIES, FORCE READINGS WERE OBSERVED TO BE NORMAL. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES.. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. FORCE SENSOR CALIBRATION TEST CONFIRMED SENSOR IS DETECTING CORRECT FORCE AT 5 LBS. PUMP EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED THAT HE RECEIVED 3 OCCLUSION ALARMS WITHIN A 4 HOUR PERIOD AFTER CHANGING THE SITE. PRIOR TO THE SITE CHANGE, THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS REPORTEDLY WITHIN NORMAL LIMITS. THE ALARMS REPORTEDLY OCCURRED DURING BOLUS ATTEMPTS. THE PATIENT ALSO CLAIMED THAT DURING THE TIME OF CONCERN, HIS BG LEVEL REACHED "600 MG/DL". HE ALSO REPORTEDLY DEVELOPED SYMPTOMS OF NOT FEELING WELL, AND BEING LETHARGIC AND IRRITABLE. THE PATIENT'S MOTHER WAS REPORTEDLY TREATING HIM WITH INSULIN VIA SYRINGES. THE PATIENT DECLINED TO HAVE THE SITE DURING THE CONTACT WITH THE ANIMAS REPRESENTATIVE. THE PATIENT'S MOTHER WAS GOING TO CHANGE THE SITE IN THE MORNING WHEN HE WAKES UP. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS SUCCESSFULLY PRIMED WITHOUT ANY OCCLUSION ALARMS OCCURRING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED AN ELEVATED BG LEVEL THAT MEETS ANIMAS' CRITERIA FOR A SERIOUS INJURY. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE ERROR SINCE THE PATIENT DEVELOPED THE HIGH BG DURING OR AFTER THE TIME HE RECEIVED 3 OCCLUSIONS ALARMS. THE PUMP ALARMS THE USER OF THE ISSUE AND THE (B)(4) INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    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 Life Threatening