FDA Adverse Event
Malfunction
Summary report: N
IMMAGE IMMUNOCHEMISTRY SYSTEM
MDR report key: 2461693
·
Received February 20, 2012
Report
- Report Number
- 2050012-2012-00524
- Event Type
- Malfunction
- Date Received
- February 20, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 1, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQX
- PMA / PMN Number
- K962294
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(4) 2012, CUSTOMER REPORTED THAT SAMPLE SYRINGE WAS LEAKING ON THE IMMAGE 800 SYSTEM. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE REAGENT SYRINGE VALVE. THIS RESOLVED THE ISSUE AND NO FURTHER ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMAGE IMMUNOCHEMISTRY SYSTEM | NEPHELOMETER, FOR CLINICAL USE | JQX | BECKMAN COULTER, INC. | IMMAGE 800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |