N
Patient 1
DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED IDENTIFICATION NUMBER. THE SERIAL NUMBER WAS RELEASED MEETING ALL QA SPECIFICATIONS. (B)(4).
MAUDE MDR 6567362
- MDR report key
- 6567362
- Report number
- 1222780-2017-00124
- Event key
- 0
- Event type
- 3
- Date received
- 2017-05-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SIDRA PIRACHA
- Address
- 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US
- Phone
- 508-508-5082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | THINPREP 5000 PROCESSOR | THINPREP 5000 PROCESSOR | HOLOGIC, INC | MKQ | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-15 | 0 | 1. R |
Event Narratives#
D
Patient 1
CUSTOMER REPORTED AN ANOMALY WITH A SAMPLE PREPARATION. A CERVICAL SAMPLE PROCESSED ON THE THINPREP 5000 PROCESSOR, WHICH WAS THEN CLASSIFIED AS NEGATIVE. THE SAMPLE WAS THEN RE-PROCESSED ON THE THINPREP 2000 PROCESSOR, AS PART OF THE LABORATORY STAIN CHECK PROCEDURE. ON CHECKING THIS SAMPLE UNDER THE MICROSCOPE IT WAS NOTED THAT THE SAMPLE CONTAINED HIGH GRADE DYSKARYOSIS. ON RE-SCREENING THE ORIGINAL SLIDE THIS WAS FOUND TO BE NEGATIVE, WHICH WAS CONFIRMED BY TWO CHECKERS AND A CONSULTANT. TO CHECK THAT THE THINPREP 2000 PROCESSOR STAIN CHECK SAMPLE WAS MADE FROM THE CORRECT VIAL THE CUSTOMER MADE A THIRD SLIDE ON THE THINPREP 2000 PROCESSOR WHICH AGAIN HAD SIMILAR HIGH GRADE DYSKARYOTIC CELLS PRESENT AS THOSE SEEN IN THE STAIN CHECK SLIDE. THE CUSTOMER RE-ISSUED THE REPORT TO THE SAMPLE TAKER AS MODERATE DYSKARYOSIS. THE LAB IS CONFIDENT THE VIALS WERE NOT MIXED UP AS THEY DO NOT KEEP PATIENT SAMPLES IN THE ROOM WITH THE THINPREP 2000 PROCESSOR. THEY ONLY KEEP THE NEW VIALS AND THE SAMPLES THEY ARE PREPPING. OLD SAMPLES ARE KEPT IN ANOTHER ROOM DOWN THE CORRIDOR. THE PATIENT WENT FOR A COLPOSCOPY WHICH REVEALED A THE SECTION SHOWS ECTOCERVICAL MUCOSA AND FREELYING FRAGMENTS OF BENIGN ENDOCERVICAL EPITHELIUM. THE TRANSFORMATION ZONE IS NOT INCLUDED. NO CIN SEEN. THE COLPOSCOPISTS OPINION IS LISTED ON CYRES COLPOSCOPY AS "OTHER". SO THE BIOPSY WAS NEGATIVE BUT THE COLPOSCOPISTS OPINION ON THE SYSTEM IS NOT NEGATIVE' OR NORMAL'. THE SYSTEM WAS CHECKED AND NO ISSUES WERE FOUND, SYSTEM OPERATIONAL. BASED ON THE INCONCLUSIVE FINDINGS THIS EVENT IS BEING REPORTED.