FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® LINKASSIST
MDR report key: 3757231
·
Received April 17, 2014
Report
- Report Number
- 1823260-2014-02825
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- April 9, 2014
- Report Date
- May 28, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- KZH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT'S INSERTION DEVICE RELEASED UNINTENTIONALLY AFTER THE PATIENT UNLOCKED THE DEVICE. NO ADVERSE EVENT WAS REPORTED. THE INSERTION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234387 | ACCU-CHEK ® LINKASSIST | SPRING LOADED INSERTION DEVICE | KZH | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 053 YR |