BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3230991 · Received July 17, 2013

    Report

    Report Number
    2183996-2013-01314
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    July 4, 2013
    Report Date
    August 29, 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
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATION 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 HIS BLOOD GLUCOSE WAS 473 MG/DL AT 10:44 A.M. AND 488 MG/DL AT 9:16 P.M. ON (B)(6) 2013. HE WAS UNABLE TO LOWER HIS BLOOD GLUCOSE BY DELIVERING BOLUSES, AND HE DISCONNECTED THE INFUSION DEVICE AND DELIVERED 10 UNITS OF INSULIN VIA PEN AROUND 9:16 P.M. AT 10:00 A.M. ON (B)(6) 2013, HIS BLOOD GLUCOSE WAS 50 MG/DL. HE WAS NOT CONNECTED TO THE INFUSION DEVICE AT THAT TIME. HE NOTICED THE CARTRIDGE WAS EMPTY ON (B)(6) 2013 AND REPORTED THE INFUSION DEVICE DID NOT PROVIDE A W1 CARTRIDGE LOW OR E1 CARTRIDGE EMPTY ERROR. HE COULD NOT REMEMBER IF THE CARTRIDGE WAS FULL WHEN IT WAS INSERTED BUT IS CERTAIN THE PISTON ROD MET THE CARTRIDGE PLUNGER. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331380 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR AVIVA COMBO METER| APIDRA (FLEX PEN)| ASTHMA MEDICATION| APIDRA| MEMORY MEDICATION