MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[42873388]
A customer in (b)(6) reported their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide. The slides were processed on (b)(6) 2016. Based on the pictures that were obtained the quality of these labels/barcodes have deteriorated compared to last time. It was noted that the barcode in question is very poor in the fact that it has ink bleed and bare patches. The instrument gave no error code for slide id (b)(6). It was confirmed that all faulty slide id's were found and reprocessed, and there was no patient recall or delay in diagnosis as a result. Customer has two different barcodes on vial, advised customer to strike through redundant barcode with black marker. Hologic field service engineer confirmed and reproduced error. Performed preventative maintenance per technical documentation. Instrument operational. Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00073 |
| MDR Report Key | 5536228 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-30 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2016-03-30 |
| 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 | 0 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-03-30 |
| 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. Other | 2016-03-30 |