FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2081623
·
Received April 13, 2011
Report
- Report Number
- 2183996-2011-01009
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- November 15, 2010
- Report Date
- March 15, 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
- UK
- 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 EXPERIENCING INSULIN LEAKAGE WHILE USING THE INFUSION SETS. THE LEAK OCCURRED DURING BOLUSING. SHE NOTICED THE ISSUE RIGHT AWAY AND HER BLOOD GLUCOSE WAS NOT AFFECTED. SHE ALSO REPORTED THE CANNULA LEFT A LARGER THAN NORMAL HOLE IN HER SKIN. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVAL.
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 | GWX133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION PUMP| INSULIN |