FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 2012961
·
Received March 4, 2011
Report
- Report Number
- 2183996-2011-00457
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- January 14, 2011
- Report Date
- March 2, 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
- EZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE 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
THE PT REPORTED SEGMENTS OF THE INFUSION DEVICE DISPLAY ARE MISSING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.
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 |