MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-07 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc..
[35739960]
A customer in the us reported diagnostic cells outside the 22 fields of view (fov). Hologic's cytology applications specialist (cas) spoke with the customer about the 6 cases with possible diagnostic cells outside of the 22 fov. The cas told the customer she would like to schedule some time to blindly review those 6 potential misses. The customer asked if the cas could postpone a visit until after the new year. The customer felt there was no urgency for the cas to visit. The visit was tentatively scheduled for (b)(6). The customer rescheduled the appointment until (b)(6). Hologic will continue investigating this complaint and will submit a supplemental mdr to fda when more information is available.
Patient Sequence No: 1, Text Type: D, B5
[37573474]
On jan 22, 2016 hologic's cas reviewed the cases blindly. Once completed the cas reviewed the cases on the double head review scope with the customer ((b)(6)). They reviewed the fov's in all the cases together. The cas found enough in the fov's for the missed cases to warrant a full review. The supervisor ((b)(6)) agreed that these misses were due to ct failure rather than instrument failure. Therefore, this is not a reportable event as initially filed via 1222780-2016-00003.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2016-00003 |
| MDR Report Key | 5351545 |
| Date Received | 2016-01-07 |
| Date of Report | 2016-01-06 |
| Date Mfgr Received | 2016-01-22 |
| Date Added to Maude | 2016-01-07 |
| 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 | EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-07 |