MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for VENTANA manufactured by Ventana/roche.
[95756342]
Ventana detection kit dispenser has been malfunctioning for ihc antibodies, not limited to lot numbers or staining platform. Multiple anatomic lab locations have been experiencing staining failures, and potential false negative immunohistochemical stain results. Several complaints have been places with ventana, however, no resolution has been provided by the company. As well as no notification from the company that there has been changes or they are aware of the issues. We were told by our ventana service rep that a resolution would be provided to our company by early december. All ihc antibodies performed using the ventana detection and the ulta and xt ventana instruments. Happening at multiple locations ((b)(6)) in our company. Reached out to other laboratories such as (b)(6), who are also experiencing the same problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074172 |
| MDR Report Key | 7142055 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-12-20 |
| Date Added to Maude | 2017-12-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTANA |
| Generic Name | IHC DISPENSER KIT |
| Product Code | NJT |
| Date Received | 2017-12-21 |
| Returned To Mfg | 2017-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA/ROCHE |
| Manufacturer Address | TUCSON AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |