FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® LINKASSIST
MDR report key: 3884428
·
Received June 19, 2014
Report
- Report Number
- 1823260-2014-04479
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 8, 2014
- Report Date
- August 27, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- KZH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTED HAVING CONCERNS WITH THE ACCU-CHEK LINKASSIST. CALLER STATED THE DEVICE DOES NOT RELEASE THE INFUSION SET AND SOMETIMES THE INFUSION SET IS RELEASED UNINTENTIONALLY. CALLER REPORTED PATIENT'S HUSBAND HAS BEEN POKED TWICE IN THE FINGER BECAUSE OF THE INFUSION SET BEING RELEASED UNINTENTIONALLY. NO OUTSIDE ASSISTANCE WAS REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED ACCU-CHEK LINKASSIST FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361948 | ACCU-CHEK ® LINKASSIST | SPRING LOADED INSERTION DEVICE | KZH | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 031 YR |