FDA Adverse Event
Malfunction
Summary report: N
SLIDEPREP PLUS CYTOLOGY CENTRIFUGE
MDR report key: 2744481
·
Received August 30, 2012
Report
- Report Number
- 1721649-2012-00002
- Event Type
- Malfunction
- Date Received
- August 30, 2012
- Report Date
- August 31, 2012
- Manufacturer
- SEPARATION TECHNOLOGY, INC., PART OF THERMO FISHER SCIENTIFIC
- Product Code
- JQC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES ARE ASSIGNED IN 1721649-2012-00001, BECAUSE BOTH REPORTED INCIDENTS INVOLVE THE SAME CYTOCENTRIFUGE.
Description of Event or Problem · 1
DURING THE INVESTIGATION OF THE INCIDENT DESCRIBED IN REPORT 1721649-2012-00001, THE LABORATORY TECHNICIAN STATED THAT THE INCIDENT HAD OCCURRED ONE OTHER TIME PREVIOUSLY. THE LABORATORY TECHNICIAN WAS NOT ABLE TO PROVIDE DETAILS ON THE OTHER INCIDENT, OTHER THAN TO SAY THAT THE INCIDENT INVOLVED THE SAME CYTOCENTRIFUGE AND THAT THE CYTOCENTRIFUGE BEGAN TURNING IN THE SAME MANNER AS DESCRIBED IN 1721649-2012-00001. BECAUSE THE INCIDENT INVOLVED THE SAME CYTOCENTRIFUGE, THE INVESTIGATION RESULTS ARE DESCRIBED IN 1721649-2012-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIDEPREP PLUS CYTOLOGY CENTRIFUGE | SLIDEPREP PLUS | JQC | SEPARATION TECHNOLOGY, INC., PART OF THERMO FISHER SCIENTIFIC | 100-400 | 033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |