BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3221245 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01268
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE BASAL RATES THAT ARE PROGRAMMED IN THE INFUSION DEVICE ARE CHANGING AUTOMATICALLY. HE SPOKE WITH A TRAINER ON (B)(6) 2013 REGARDING HYPERGLYCEMIA. SHE RECOMMENDED HE INCREASE HIS BASAL RATES TO 1.75 UNITS PER HOUR FOR ALL 24 HOURS. HE PROGRAMMED THE BASAL RATES, AND HIS BLOOD GLUCOSE STARTED TO DECREASE AND THEN INCREASED AGAIN. HE LOOKED AND FOUND THE BASAL RATES AUTOMATICALLY CHANGED TO 1.2 UNITS PER HOUR. DURING THE TROUBLESHOOTING CALL, HE VERIFIED THERE WAS ONLY 1 BASAL RATE PROFILE. THE BASAL RATES WERE SET TO 1.75 UNITS PER HOUR, BUT HE REPORTED HE MADE THIS CHANGE 30 MINUTES PRIOR TO CALLING. HE REPORTED HE PRESSED THE CHECK BUTTON TWICE TO CONFIRM AND SAVE THE RATES. HE BOLUSED AND INCREASED THE BASAL RATES TO TREAT HYPERGLYCEMIA. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. HE CALLED AT 9:00 A.M. ON (B)(6) 2013 TO CHECK THE STATUS OF THE REPLACEMENT AND REPORTED HIS BLOOD GLUCOSE WAS 400 MG/DL THROUGHOUT THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320844 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR LISINOPRIL| NOVOLOG