BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2992051 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00336
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 4, 2012
    Report Date
    May 7, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT RESULT THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND CAUSED DAMAGES TO THE PUMP ELECTRONICS. THE DAMAGES LED TO THE TRIGGERING OF ELECTRONIC ERRORS. THE ERROR E8 IS A CONSEQUENCE ERROR OF THE DAMAGED PUMP ELECTRONICS DUE TO LIQUID INGRESS. CONSUMABLES THE ADAPTER PASSED NOT THE OPTICAL INSPECTION. THE BATTERY COVER PASSED THE OPTICAL INSPECTION. AS THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED HIS HBA1C HAD BEEN 6.5 AND HIS BLOOD GLUCOSE LEVELS HAD BEEN IN THE 200'S-300'S MG/DL. HIS NORMAL RANGE IS 120-140 MG/DL. THE PATIENT HAS BOLUSED TO CORRECT THE ELEVATED BLOOD GLUCOSE LEVELS. HIS PHYSICIAN ADVISED HIM TO INCREASE HIS BASAL RATES. TROUBLE SHOOTING WITH THE PATIENT DID NOT IDENTIFY ANY PROBLEMS WITH THE INFUSION DEVICE. DURING FOLLOW-UP WITH THE PATIENT HE STATED THAT HE THOUGHT HIS ELEVATED BLOOD GLUCOSE LEVELS WERE CAUSED BY A NEW MEDICATION, DOCQLICE, BUT THEN HE CALLED BACK AND STATED THAT HE HAD STOPPED TAKING THE MEDICINE AND HIS BLOOD GLUCOSE LEVELS WERE STILL ELEVATED. HE STATED THAT HE DID NOT THINK THE INFUSION DEVICE WAS DELIVERING THE BASAL RATE CORRECTLY. HE STATED THAT HIS BLOOD GLUCOSE LEVEL HAD BEEN FROM 140-300 MG/DL AND WHEN IT WAS IN THE 300'S MG/DL HE WOULD HAVE TO BOLUS 25 UNITS OF INSULIN TO GET IT TO LOWER. THE PATIENT'S BLOOD GLUCOSE LEVELS RETURNED TO NORMAL WHEN HE SWITCHED TO HIS BACKUP INFUSION DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE ACCESSORIES WERE DISCARDED BY THE PATIENT. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97594 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR LEVOTHYROXINE| HUMALOG| MENTENEX| ANDROGEL| NERO SPINAL STIMULATORS| BYSTOLIC| LIPITOR