FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2141044
·
Received June 16, 2011
Report
- Report Number
- 2183996-2011-01611
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 19, 2011
- Report Date
- May 11, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYS INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LO
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PT REPORTED THE INFUSION DEVICE DISPLAYED E7 ELECTRONIC ERROR, AND THE BUTTONS ON THE INFUSION DEVICE WOULD NOT FUNCTION. BATTERY WAS REMOVED FROM THE INFUSION DEVICE FOR 2 HOURS, BUT THE ISSUE PERSISTED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL INFO WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN |