FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2253759
·
Received August 10, 2011
Report
- Report Number
- 2183996-2011-02180
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 20, 2011
- Report Date
- August 1, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- LZG
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1487-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
ON (B)(6) 2011 THE PT REPORTED EXPERIENCING A BENT CANNULA APPROX ONE WEEK PRIOR (B)(6) 2011. SHE WAS ADVISED OF THE RECALL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS | INSULIN INFUSION SET | LZG | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | GWX042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | INSULIN INFUSION PUMP| INSULIN |