FDA Adverse Event
Summary report: N
THINPREP 5000 PROCESSOR
MDR report key: 3926641
·
Received June 17, 2014
Report
- Report Number
- 1222780-2014-00102
- Date Received
- June 17, 2014
- Date of Event
- January 1, 2014
- Report Date
- May 27, 2014
- Manufacturer
- HOLOGIC INC.
- Product Code
- MKQ
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THEIR THINPREP 5000 WAS INTERMITTENTLY BREAKING SLIDES. CUSTOMER STATED THAT TWO PATIENT NEEDED TO BE CALLED BACK TO THE DOCTOR'S OFFICE TO RECOLLECT LOST SAMPLES. HOLOGIC FIELD SERVICE ENGINEER CONFIRMED BUT WAS UNABLE TO REPRODUCE THE ERROR. THE FIELD SERVICE ENGINEER REPLACED THE FOLLOWING PART AS A PRECAUTION; SLIDE Z CICOIL, SLIDE X CICOIL, GALIL 1. PERFORMED ALL REQUIRED SETUPS PER TECHNICAL DOCUMENTATION. RAN ALL NON-INTERACTIVE MOTION TESTS TO VERIFY INSTRUMENT OPERATION RAN GO NO-GO TEST TO VERIFY INSTRUMENT OPERATION PROCESSED SAMPLES TO CONFIRM OPERATION. INSTRUMENT IS OPERATIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353772 | THINPREP 5000 PROCESSOR | THINPREP 5000 PROCESSOR | MKQ | HOLOGIC INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |