FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK SPIRIT COMBO

MDR report key: 2081606 · Received April 13, 2011

Report

Report Number
2183996-2011-01011
Event Type
Malfunction
Date Received
April 13, 2011
Date of Event
January 20, 2011
Report Date
March 15, 2011
Manufacturer
ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code
LZG
PMA / PMN Number
NA
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SP
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

THE PT REPORTED THE INFUSION DEVICE DISPLAYS E8 (POWER INTERRUPT) ERROR, E10 (CARTRIDGE) ERROR, AND E2 (BATTERY DEPLETED) ERROR. AFTER CHANGING THE BATTERY, THE E8 AND E10 OCCURRED. THE INFUSION DEVICE DOES NOT RESPOND TO ANY BUTTON PRESSES. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED. THE BATTERY SPRING IS LOOSENED, THE BATTERY COMPARTMENT AND THE CONTACT CLASPS OF THE SUPPLY BOARD ARE CORRODED. THE CORROSION IS CAUSED BY BATTERY ACID FROM A LEAKED BATTERY. THE PT MAY HAVE USED AN INAPPROPRIATE OR OLD BATTERY. E2 WERE FOUND IN THE HISTORY. DUE TO THE CORROSION, THE PUMP HAD AN HIGHER POWER CONSUMPTION AND LED TO EARLIER TRIGGERED E2 ERROR MESSAGES. THE E2 OCCURS IF THE BATTERY IS EMPTY. E8 (S) WERE FOUND IN THE HISTORY. THE PUMP DID RESTART SOMETIMES BY ITSELF DUE TO THE CORROSION. THE PUMP TRIGGERED, ALWAYS CORRECTLY, AN E8 ERROR MESSAGE. A POWER INTERRUPT (E8) MAY OCCUR WHEN YOU INSERT A NEW BATTERY WITHOUT PUTTING YOUR INSULIN PUMP INTO STOP MODE FIRST, OR WHEN YOUR INSULIN PUMP WAS DROPPED. E10 (S) WERE FOUND IN THE HISTORY. THE PUMP RESTARTED BY ITSELF DUE TO THE CORROSION DURING A CARTRIDGE CHANGE AND LED TO E10 ERROR MESSAGES. THE E10 OCCURS IF THE REWIND OF THE PISTON ROD WAS NOT SUCCESSFULLY ACCOMPLISHED. THE PROBLEM WITH THE CHECK BUTTON MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE CHECK BUTTON WAS VISUALLY INSPECTED AND MEETS THE SPECIFICATION. THE BUTTONS MAY NOT HAVE FUNCTIONED PROPERLY DUE TO THE ISSUE WITH THE CORROSION. THE ISSUE IS RELATED TO USER HANDLING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 INSULIN INFUSION SET| INSULIN