FDA Adverse Event
Summary report: N
THINPREP 5000 PROCESSOR
MDR report key: 5065063
·
Received September 9, 2015
Report
- Report Number
- 1222780-2015-00158
- Date Received
- September 9, 2015
- Report Date
- September 9, 2015
- Manufacturer
- HOLOGIC, INC
- Product Code
- MKQ
- Report Source
- Manufacturer report
- Reporter Location
- IO
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CUSTOMER REPORTED IN (B)(6) THAT THEIR THINPREP 5000 PROCESSOR AUTOLOADER ETCHED A WRONG VIAL ID ONTO A SLIDE. NO PATIENT RECALL WAS REQUIRED AS SUFFICIENT SAMPLE WAS LEFT TO REPROCESS THE VIAL. AFTER 250+ ATTEMPTS HOLOGIC'S FIELD SERVICE ENGINEER WAS UNABLE TO REPRODUCE THE ERROR. HOLOGIC'S FIELD SERVICE ENGINEER FOUND THE MOST LIKELY CAUSE OF THE ERROR BEING CAUSED BY A BARCODE SHINING THROUGH UNDERNEATH LABEL. INSTRUMENT IS OPERATIONAL. THIS IS CONSIDERED A REPORTABLE EVENT SINCE THE THINPREP 5000 PROCESSOR AUTOLOADER DID NOT PERFORM AS INTENDED AND THIS COULD POTENTIALLY LEAD TO TA MISDIAGNOSIS OR DELAY IN DIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594564 | THINPREP 5000 PROCESSOR | THINPREP 5000 PROCESSOR | MKQ | HOLOGIC, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |