FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS INFUSION SET
MDR report key: 2022204
·
Received March 11, 2011
Report
- Report Number
- 2183996-2011-00522
- Event Type
- Malfunction
- Date Received
- March 11, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011 PT REPORTED SHE NOTICED THE INFUSION SET LEAKED AFTER BOLUSING. PT STATED SHE IS NOT HAVING THE LEAKING AT THE TIME OF THE CALL. PT REPORTED SHE DOES NOT KNOW WHERE THE INFUSION SET IS LEAKING FROM. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | INSULIN| INSULIN INFUSION PUMP |