FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 2112219
·
Received April 29, 2011
Report
- Report Number
- 2183996-2011-01303
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 12, 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 OF 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 A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PATIENT REPORTED, THE INFUSION DEVICE SHUT DOWN WITHOUT PROVIDING A W2 LOW BATTERY ALERT. 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. ADDITIONAL INFORMATION WAS NOT PROVIDED.
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 |