FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK FLEXLINK PLUS INFUSION SET
MDR report key: 1855178
·
Received September 30, 2010
Report
- Report Number
- 2183996-2010-02031
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 15, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PT REPORTED THAT THE INFUSION SET TUBING COMPLETELY SEPARATED FROM THE LUER CONNECTION RESULTING IN SLIGHTLY ELEVATED BLOOD GLUCOSE OF 179 MG/DL. SHE CHANGED THE INFUSION SET AND BOLUSED TO LOWER HER BLOOD GLUCOSE. THE INFUSION TUBING HAD BEEN IN USE FOR 3 DAYS. 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 RETUNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS INFUSION SET | INSULIN INFUSION SET | FPA | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INSULIN INFUSION PUMP| INSULIN |