FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 2080289
·
Received April 6, 2011
Report
- Report Number
- 2183996-2011-00861
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- February 12, 2011
- Report Date
- March 9, 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
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES.
Description of Event or Problem · 1
PT REPORTED THE MENU BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION PROPERLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE INFUSION DEVICE WAS EVALUATED, AND THE MENU BUTTON DOES NOT RESPOND. THERE ARE PARTICLES OF PLASTIC INSIDE THE HOUSING OF THE MENU BUTTON, AND THESE PARTICLES TEMPORARILY ISOLATE THE AREA OF CONTACT INSIDE THE BUTTON HOUSING. DUE TO THIS , THE MENU BUTTON IS WITHOUT FUNCTION.
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| INSULIN INFUSION SET |