BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2618340 · Received June 15, 2012

    Report

    Report Number
    2531779-2012-05321
    Event Type
    Death
    Date Received
    June 15, 2012
    Date of Event
    May 12, 2012
    Report Date
    May 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE REPORTED DATE OF DEATH WAS (B)(6) 2012. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP WAS OPERATING UNTIL (B)(6) 2012. THE BOLUS HISTORY INDICATED THAT THE LAST BOLUS WAS DELIVERED AT 7:30 AM ON (B)(6) 2012. THE PUMP'S FINAL BASAL DELIVERY OCCURRED AT 1:53 PM ON (B)(6) 2012. THE PUMP WAS SUSPENDED ON (B)(6) 2012 AT 4:11 PM AND RESUMED ON (B)(6) 2012 AT 10:32 AM. THERE WERE NO ALARMS OUTSIDE THE RANGE OF NORMAL USE OBSERVED IN THE PUMP HISTORIES. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES AND NO ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THE REPORTER AGREED TO RETURN THE PUMP FOR INVESTIGATION. HOWEVER, THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2012, IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2012; THE CAUSE OF DEATH PER DEATH CERTIFICATE WAS METASTATIC SQUAMOUS CELL CANCER OF UNKNOWN PRIMARY ORIGIN. THE FOLLOWING SEQUENCE OF EVENTS LEADING UP TO THE PATIENT'S DEATH WAS PROVIDED BY TWO REPORTERS: THE REPORTERS STATED THAT THE PATIENT HAD DEVELOPED A POOR MEMORY AND WAS IN PAIN DUE TO THE CHEMOTHERAPY AND CANCER; THEY SAID THAT RECENTLY THE PATIENT WAS NOT EATING BUT THE PUMP WAS STILL DELIVERING BASAL INSULIN. ON (B)(6) 2012, THE PATIENT WAS FOUND BY ONE OF THE REPORTERS IN A COMA AND WAS TRANSPORTED BY EMERGENCY MEDICAL TECHNICIANS (EMT) TO THE HOSPITAL. EMT TOLD THE REPORTERS THAT THE PATIENT WAS IN A DIABETIC COMA; THE REPORTERS SAID THAT THE PATIENT'S BG WAS TOO LOW TO BE MEASURED. THE PUMP SAID TO HAVE BEEN REMOVED UPON ARRIVAL AT THE HOSPITAL. THE REPORTERS SAID THAT THE PATIENT HAD A DIRECTIVE FOR NO LIFE SUPPORT AND HE DIED TWO DAYS LATER. THE REPORTERS STATED THAT THEY THOUGHT THE CAUSE OF DEATH WAS DIABETIC COMPLICATIONS. HOWEVER, THEY DID NOT ATTRIBUTE THE PATIENT'S DEATH TO A PUMP MALFUNCTION OR DEFECT. ONE OF THE REPORTERS SAID THAT SHE USES A PUMP; SHE REVIEWED THE PATIENT'S PUMP SETTINGS AND HISTORY. SHE SAID THAT SHE DID NOT FIND ANYTHING UNUSUAL. THERE WERE NO BOLUSES ON THE DAY OF HIS DEATH; THE BASAL RATE WAS DELIVERED AS PROGRAMMED. SHE REPORTED THAT THE PATIENT HAD MULTIPLE LOW BG READINGS (AROUND 40MG/DL) DURING THE TIME LEADING UP TO HIS DEATH, AND SAID THAT SHE THOUGHT THE PATIENT'S PHYSICIAN SHOULD HAVE TAKEN HIM OFF THE PUMP BECAUSE OF HIS CONDITION. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALTHOUGH THERE IS NO ALLEGATION OR EVIDENCE OF A PRODUCT FAULT, THE POSSIBILITY OF USE ERROR CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE HYPOGLYCEMIA THAT OCCURRED PRIOR TO THE PATIENT'S DEMISE.

    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 64 YR Death