FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2030704
·
Received March 22, 2011
Report
- Report Number
- 2183996-2011-00579
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1486-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE 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 THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
OFTEN THE INFUSION CANNULAS ARE CRIMPED AND THIS RESULTS IN TOO HIGH OF A BLOOD GLUCOSE LEVEL. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | GWX009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION DEVICE |