FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1901124
·
Received November 10, 2010
Report
- Report Number
- 2183996-2010-02285
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- June 28, 2010
- Report Date
- October 14, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1415-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
INFUSION DEVICE UP/DOWN BUTTON WAS DEFECTIVE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | INSULIN| INSULIN INFUSION SET |