MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[45097741]
Customer in (b)(6) reported their thinprep 5000 processor with autoloader printed a wrong vial id onto a slide. The instrument did not present any error to the operator. The customer sent pictures to (b)(4) for investigation and it was noted that the customer is using 1d barcodes on both slide and vial. It was confirmed that the sample was reprocessed without error on the same t5 autoloader. No patient recall or diagnosis delay noted. Fse confirmed but unable to reproduce error. Found the following to be the most likely cause of the error. Barcode scanner, scanner upgraded as part of (b)(4), documented on (b)(4). Processed samples to confirm operation. 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 | 1222780-2016-00110 |
| MDR Report Key | 5632631 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-04 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-05-04 |
| 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 | 5082638884 |
| 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 | 2016-05-04 |
| 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 | 2016-05-04 |