FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 2072996
·
Received April 21, 2011
Report
- Report Number
- 2183996-2011-01178
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 27, 2011
- Report Date
- March 30, 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. NO PRODUCT WAS RETURNED FOR EVALUATION.
Description of Event or Problem · 1
PT REPORTED, THE CHECK BUTTON ON THE INFUSION DEVICE WAS DAMAGED. 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 FOR EVALUATION. F/U WAS PROVIDED BY THE PT WHO REPORTED THE INFUSION DEVICE FUNCTIONED AS INTENDED AFTER THAT EVENT, AND THERE WERE NO FURTHER CONCERNS. PT REPORTED THE PRODUCT WOULD NOT BE RETURNED FOR EVALUATION. THE PRODUCTION REPORTS WERE REVIEWED. THE PRODUCTION DATA COMPLY WITH SPECIFICATIONS, AND THE COMPLAINT COULD NOT BE REPLICATED.
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 |