FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® LINKASSIST
MDR report key: 3738079
·
Received April 10, 2014
Report
- Report Number
- 1823260-2014-02546
- Event Type
- Malfunction
- Date Received
- April 10, 2014
- Date of Event
- March 28, 2014
- Report Date
- May 6, 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
PATIENT REPORTED THE INSERTER DEVICE DOES NOT WORK PROPERLY. PATIENT STATED THE DEVICE SOMETIMES DOES NOT RELEASE THE CANNULA AND THEN SOMETIMES IT RELEASES THE CANNULA UNINTENTIONALLY. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REPORT NEEDING ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INSERTION ASSIST DEVICE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218190 | ACCU-CHEK ® LINKASSIST | SPRING LOADED INSERTION DEVICE | KZH | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 034 YR |