FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® LINKASSIST
MDR report key: 3852066
·
Received June 5, 2014
Report
- Report Number
- 1823260-2014-04066
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 18, 2014
- Report Date
- August 8, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- KZH
- PMA / PMN Number
- K063146
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED ATTEMPTING TO CHANGE HER HEADSET AND THE INSERTION ASSIST DEVICE UNINTENTIONALLY RELEASED THE INFUSION SET. CALLER STATED THIS IS THE FIRST TIME THIS ISSUE OCCURRED. CALLER REPORTED THE INSERTION ASSIST DEVICE HAS SOMETIMES NOT EJECTED THE INFUSION SET AFTER SHE PRESSED THE RELEASE BUTTON. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INSERTION ASSIST DEVICE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329496 | ACCU-CHEK ® LINKASSIST | SPRING LOADED INSERTION DEVICE | KZH | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |