FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK D-TRONPLUS
MDR report key: 2222879
·
Received July 15, 2011
Report
- Report Number
- 2183996-2011-02038
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 10, 2011
- Report Date
- July 7, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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
PT REPORTED THE MENU BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK D-TRONPLUS | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN |