FDA Adverse Event
Malfunction
Summary report: N
COULTER LH500
MDR report key: 2022884
·
Received March 18, 2011
Report
- Report Number
- 1061932-2011-00152
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K042724
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) ADJUSTED THE ALIGNMENT OF THE RINSE BLOCK. THE FSE VERIFIED THE REPAIR AND VALIDATED THE INSTRUMENT. ROOT CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE RINSE BLOCK WAS LEAKING ISOTON AND POSSIBLY LATRON PRIMER WHEN THEY RAN THE INSTRUMENT IN SECONDARY MODE. THE OPERATOR WAS WEARING LAB COAT AND GLOVES. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT AND THE OPERATOR DID NOT SEEK MEDICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH500 | AUTOMATED DIFFERENTIAL CELL COUNTER | GKZ | BECKMAN COULTER, INC. | LH500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |