BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3706330 · Received March 27, 2014

    Report

    Report Number
    1823260-2014-02143
    Event Type
    Death
    Date Received
    March 27, 2014
    Date of Event
    December 30, 2013
    Report Date
    March 27, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER FROM (B)(6) STATED THE PATIENT WAS FOUND UNCONSCIOUS AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. DUE TO A DOMESTIC DISPUTE, THE PATIENT HAD SECLUDED HERSELF IN A BEDROOM AND WAS NOT ACCESSIBLE FOR AN UNDISCLOSED AMOUNT OF TIME. UPON FORCING THE DOOR OPEN, THE PATIENT WAS FOUND UNCONSCIOUS WITH THE INFUSION DEVICE SYSTEM IN USE. THE SYSTEM WAS POWERED DOWN ON (B)(6) 2013. THE CORONER REPORTED THE INFUSION DEVICE WOULD HAVE BEEN REMOVED AT THE TIME OF ADMISSION; HOWEVER, THIS CANNOT BE CONFIRMED. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2013. THE CORONER STATED THE CAUSE OF DEATH WAS AN "INSULIN OVERDOSE;" HOWEVER, THE OFFICIAL CAUSE OF DEATH HAS NOT BEEN DETERMINED. THE SUSPECT SYSTEM WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. DURING THE INVESTIGATION, THE FOLLOWING DATA WAS DOWNLOADED FROM THE SYSTEM: INFUSION DEVICE BOLUS HISTORY- (B)(6) 2013 14:46 INFUSED_DOSE=3.0 IU, (B)(6) 2013 15:56 INFUSED_DOSE=3.0 IU, (B)(6) 2013 17:39 INFUSED_DOSE=3.4 IU, (B)(6) 2013 8:56 INFUSED_DOSE=3.0 IU, (B)(6) 2013 15:57 INFUSED_DOSE=3.5 IU, (B)(6) 2013 19:17 INFUSED_DOSE=3.0 IU, (B)(6) 2013 21:24 INFUSED_DOSE=3.0 IU, (B)(6) 2013 8:41 INFUSED_DOSE=3.0 IU. INFUSION DEVICE TOTAL DAILY DOSE - (B)(6) 2013 DAYTOTAL 35.2 IU, (B)(6) 2013 DAYTOTAL 32.8 IU, (B)(6) 2013 DAYTOTAL 32.1 IU, (B)(6) 2013 DAYTOTAL 33.2 IU, (B)(6) 2013 DAYTOTAL 30.1 IU, (B)(6) 2013 DAYTOTAL 34.7 IU, (B)(6) 2013 DAYTOTAL 31.7 IU, (B)(6) 2013 DAYTOTAL 33.1 IU, (B)(6) 2013 DAYTOTAL 30.2 IU, (B)(6) 2013 DAYTOTAL 19.8 IU. BLOOD GLUCOSE RESULTS FROM PREVIOUS 10 DAYS - (B)(6) 2013 13:44 20.4 MMOL/L, (B)(6) 2013 19:07 11.3 MMOL/L, (B)(6) 2013 17:51 11.4 MMOL/L, (B)(6) 2013 20:41 9.5 MMOL/L, (B)(6) 2013 19:37 4.9 MMOL/L, (B)(6) 2013 10:09 4.0 MMOL/L, (B)(6) 2013 18:25 6.0 MMOL/L, (B)(6) 2013 11:27 3.4 MMOL/L. THE RESULTS FROM THE INVESTIGATION CONCLUDED THAT ALL PROGRAMMED BOLUSES WERE SUCCESSFULLY DELIVERED VIA THE INFUSION DEVICE. ADDITIONALLY, THE DELIVERY ACCURACY, OCCLUSION LIMITS, AND ALARM FUNCTIONS OF THE INFUSION DEVICE WERE TESTED SUCCESSFULLY, AND WITHIN PRODUCT SPECIFICATIONS. NO MALFUNCTION OF THE DEVICE WAS OBSERVED. ACCORDING TO THE DEVICE HISTORY, ALL BOLUSES WERE MANUALLY PROGRAMMED INTO THE INFUSION DEVICE WITHOUT BLUETOOTH COMMUNICATION FROM THE BLOOD GLUCOSE MONITOR. SEVERAL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. THERE IS NO EVIDENCE A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181139 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR Death