MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-14 for AUTOSTAINER SLIDE RACKS S3704 manufactured by Dako North America, Inc.
[134584834]
As part of dako's continuous improvement process, capa (b)(4) was raised to update the dako autostainer user guide regarding a known issue, slide racks out of level failures. Capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134584835]
Summary: this report is regarding autostainer slides racks used with dako autostainer link instruments, an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the autostainer link automated workstations operating either singly or in networked configurations. (b)(6) has identified an additional correction to the risk of slide rack leveling failures as described in the current autostainer user guides. Such failures have the potential to impact staining quality with weak/uneven staining, which may lead to false negative test results. We are updating the autostainer link basic user guide to include an additional mitigation to the slide rack leveling risk. Slide racks may be affected by repeated exposure to the heat of the hot water bath of the pt link leading to the risk of level failures. We have determined that a limit of 175 uses of each slide rack will further reduce the risk of out-of-level slides. Following this update to the guide will ensure that the slide racks are not used beyond their ability to withstand the hot water bath and are replaced at a frequency appropriate for the customer's workflow. Clinical significance: if use of slide racks is in excess of 175 pt link pre-treatment cycles, then there is the possibility that out-of-level slide racks may lead to weak/uneven staining, which potentially leads to false negative test results and may impact patient treatment. If on-slide controls are run, as recommended by the autostainer user guide, the failure would be detected. In conclusion, if our recommendations, stated in the current autostainer user guide, are followed, the likelihood of risk to patients is remote.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022180-2019-00001 |
| MDR Report Key | 8243832 |
| Date Received | 2019-01-14 |
| Date of Report | 2019-05-03 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2019-01-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR THIAGO LIMA |
| Manufacturer Street | PRODUKTIONSVEJ 42 |
| Manufacturer City | GLOSTRUP, 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2600 |
| Manufacturer G1 | DAKO NORTH AMERICA, INC |
| Manufacturer Street | 6392 VIA REAL |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUTOSTAINER SLIDE RACKS |
| Generic Name | AUTOSTAINER SLIDE RACKS - KPA |
| Product Code | KPA |
| Date Received | 2019-01-14 |
| Catalog Number | S3704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAKO NORTH AMERICA, INC |
| Manufacturer Address | 6392 VIA REAL CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-14 |