FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS INFUSION SET
MDR report key: 2073009
·
Received April 21, 2011
Report
- Report Number
- 2183996-2011-01170
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1490-2011
- 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. 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 INFUSION SET WAS LEAKY. PT STATED THE SELF-ADHESIVE IS BLOODY ALSO. 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 SET FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS INFUSION SET | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | GWX018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION PUMP |