MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-05-25 for THINPREP IMAGING SYSTEM manufactured by Hologic, Inc.
[2739965]
The issue reported via a 04/26/2012 medwatch form was abnormal cells missed by thinprep imager system (i. E. Abnormal cells not present in the 22 fields of view (fov) presented). The root causes derived from past investigations of reported abnormal cells not present in the 22 fovs fall mainly into two categories: rare event - an event in which the slide falls into the category where the cells in question would match our experience in the clinical trial as evidenced in table 8 of the thinprep imaging system operation summary and clinical info. Customer miss - determined by a hologic cystology applications specialist (cas) who in a blinded manner microscopically reviews the slide (s) in question at the laboratory. The cas identifies abnormal cells (trigger cells) in the original 22 fovs which should have prompted a full scan review. The root cause is determined to be the result of diagnostic misinterpretation and not related to the function/performance of the thinprep imager. Customer and instrument info were not included on medwatch form. There is no info on pt diagnosis, nor a delay in diagnosis. If further info becomes available, a separate complaint will be opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2012-00135 |
| MDR Report Key | 2593858 |
| Report Source | 99 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-04-26 |
| Date of Event | 2010-09-14 |
| Date Mfgr Received | 2012-04-26 |
| Date Added to Maude | 2012-08-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN FARR |
| Manufacturer Street | 502 S ROSA RD |
| Manufacturer City | MADISON WI 53719 |
| Manufacturer Country | US |
| Manufacturer Postal | 53719 |
| Manufacturer Phone | 6082362525 |
| Manufacturer Street | 445 SIMARANO DR |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2012-05-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-25 |