BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3243355 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01361
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 13, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CAN BE VERIFIED. RESULT E7001 WAS FOUND IN THE HISTORY LIST. THE PUMP CORRECTLY TRIGGERED THE E7001 ERROR MESSAGES. THE BUZZER IS WITHOUT FUNCTION. NO EXACT REASON IS KNOWN AT THE TIME. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY AND COMPLY WITH THE PRODUCT SPECIFICATION. BATTERY COVER/ADAPTER: THE ADAPTER PASSED THE OPTICAL INSPECTION. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT IN THE LAST 10 DAYS SHE HAS EXPERIENCED EPISODES OF ELEVATED BLOOD GLUCOSE LEVELS. PATIENT STATED THE FIRST EPISODE WAS ON (B)(6) 2013 WHERE HER BLOOD GLUCOSE LEVEL WAS 563 MG/DL. PATIENT REPORTED SHE CHANGED THE INFUSION SET AND THAT SOLVED THE CONCERN. PATIENT STATED THE SECOND EPISODE OCCURRED ON (B)(6) 2013 AND HER BLOOD GLUCOSE LEVEL WAS 316 MG/DL. PATIENT REPORTED SHE DELIVERED A BOLUS BUT NOTHING CHANGED SO SHE THOUGHT IT WAS A CASE OF OCCLUSION BECAUSE THE INFUSION DEVICE DIDN'T WARN ANY TYPE OF ALARM OR SIGNAL. PATIENT STATED SHE REMOVED THE NEEDLE FROM HER ABDOMEN AND TRIED TO BOLUS BUT NOTHING CHANGED, SO SHE CONTINUED TO DELIVER BOLUSES UNTIL SHE SAW INSULIN DRIP. PATIENT REPORTED THAT AFTER THAT SHE RESUMED INSULIN THERAPY REGULARLY WITHOUT CHANGING THE INFUSION SET. PATIENT STATED THAT ON (B)(6) 2013 HER BLOOD GLUCOSE LEVEL WAS 334 MG/DL, SHE FOLLOWED THE SAME APPROACH AS SHE DID ON (B)(6) 2013; SHE DELIVERED A BOLUS BUT NOTHING CHANGED. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL ROSE TO 425 MG/DL, THE INFUSION DEVICE AGAIN DID NOT WARN ANY TYPE OF ALARM, SO SHE TRIED AGAIN TO REMOVE THE NEEDLE AND DELIVER BOLUSES UNTIL SHE SAW DRAIN. PATIENT STATED THAT AFTER THAT SHE RESUMED INSULIN THERAPY REGULARLY, BUT ON THIS OCCASION SHE DID NOT CHANGE THE INFUSION SET. PATIENT REPORTED THE SAME THING OCCURRED ON (B)(6) 2013 AND HER BLOOD GLUCOSE LEVEL WAS 395 MG/DL; SHE SOLVED THE CONCERN THE SAME AS ON (B)(6) 2013 AND THE INFUSION DEVICE DID NOT GIVE ANY TYPE OF WARNING SIGNAL OR ALARM. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. ADVISED PATIENT TO USE BACKUP INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, BATTERY, ADAPTER, AND BATTERY COVER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343459 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1