MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-05-15 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[75173728]
Device history record (dhr) review was conducted for the reported identification number. The serial number was released meeting all qa specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75173729]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00124 |
| MDR Report Key | 6567362 |
| Report Source | FOREIGN |
| Date Received | 2017-05-15 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082633884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2017-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-15 |