MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-25 for PATHYWAY ANTI-HER-2/NEU (4B5) RABBIT MONO 05278368001 790-2991 manufactured by Ventana Medical Systems, Inc..
[18933399]
On (b)(6) customer conducted a re-test of a breast cancer pt using pathway anti-her-2/neu (4b5) rabbit monoclonal antibody kit. The result was positive, which contradicted an (b)(6) result for the same pt. The mfr confirmed the customer was not using prescribed system controls but rather commercially available 4-in-one slides to be used in validation and troubleshooting. The customer was also found to be using questionable pre-analytical techniques for use of histopathology tissue staining kits (storage or reagents without capping to prevent drying out, use of the kits immediately from the refrigerator without warming up, etc. ).
Patient Sequence No: 1, Text Type: D, B5
[19049451]
Customer is not cooperative in providing the necessary investigational info. Final conclusion is that potentially a user error related to pre-analytical preparation resulted in a negative result in april. At some point a retest was conducted (reasons not disclosed to the mfr) by a 3rd party lab - results conflicted with the earlier test. On (b)(6) the customer repeated their test using a new lot of pathway anti-her-2/neu (4b5) rabbit monoclonal antibody, which resulted in a positive result. Customer has not confirmed any pt related impact, data details, or status. No further details are expected from the customer. This is an initial and final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2014-00002 |
| MDR Report Key | 3987591 |
| Report Source | 04 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2014-07-03 |
| Device Manufacturer Date | 2013-11-14 |
| Date Added to Maude | 2014-08-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD MOSS |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777239 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHYWAY ANTI-HER-2/NEU (4B5) RABBIT MONO |
| Generic Name | HER2 4B5 |
| Product Code | MVC |
| Date Received | 2014-07-25 |
| Model Number | 05278368001 |
| Catalog Number | 790-2991 |
| Lot Number | D09098 |
| Device Expiration Date | 2015-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-25 |