FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK INFUSION SET
MDR report key: 1913955
·
Received November 19, 2010
Report
- Report Number
- 2183996-2010-02430
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- August 2, 2010
- Report Date
- November 9, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- 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 PATIENT'S FATHER REPORTED THE INFUSION TUBING BROKE AT THE LUER CONNECTION OF THE INFUSION SET. HE STATED THIS HAS OCCURRED SEVERAL TIMES OVER THE PAST 3 MONTHS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. NO FURTHER INFO IS AVAILABLE. THE PATIENT 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 INFUSION SET | INSULIN INFUSION SET | LZG | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION PUMP |