MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-06-26 for OPTIVIEW DAB DETECTION KIT 06396500001 manufactured by Ventana Medical Systems Inc..
[18622310]
Customer noticed tissue diagnostic staining intensity issue using optiview with lot c12186. On subsequent tissue stains per the customer, numerous slides were negative. A visual check of the dispensers revealed that the h2o2 dispenser was empty with tests registered as remaining. At this time the customer has indicated one patient is potentially affected. The manufacturer is inquiring as to what the required run controls indicated for this case.
Patient Sequence No: 1, Text Type: D, B5
[18701004]
Ventana will continue to remind the customer of required controls and is also investigating the nature of the dispenser seal ("quad seal") from a supplier.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2013-00002 |
| MDR Report Key | 3197041 |
| Report Source | 01 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-05-28 |
| Date Mfgr Received | 2013-05-28 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-09-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD MOSS |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal | 857551962 |
| Manufacturer Phone | 5208777239 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVIEW DAB DETECTION KIT |
| Generic Name | OPTIVIEW DAB |
| Product Code | NJT |
| Date Received | 2013-06-26 |
| Returned To Mfg | 2013-06-24 |
| Catalog Number | 06396500001 |
| Lot Number | C12186 |
| ID Number | 760-700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-26 |