MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-02-28 for 06679072001 790-4794 manufactured by Ventana Medical Systems Inc.
[101234691]
It is unknown if there was a deterioration in patient health. We have asked the customer multiple times with no response. There is no indication of a malfunction with a ventana medical systems instrument or assay. The alk package insert 790-4796 (b)(4) and interpretation guide 790-4796 (b)(4) mandate the use of system controls run with all patient samples. The package insert specifically calls out excessive non-specific background staining of glandular epithelial cells, muscle, or lymphoid tissue that interferes with scoring as unacceptable and instructs users that if the positive or negative tissue controls fail to demonstrate appropriate staining or demonstrate a change in clinical diagnostic interpretation, any results with the test specimens should be considered invalid. In addition, the alk interpretation guide provides image examples of unacceptable background staining. Use of tissue controls is also mandated by global quality assurance organizations and quality control guidelines including the clinical laboratory improvement amendments clia regulations. This is the initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[101234692]
The alk therapy treatment resulted in patient admission to intensive care unit. Additional testing was conducted at second hospital for egfr and alk. There was high back ground staining observed however the doctor at the second hospital was able to read the slide and make the correct negative diagnosis which was confirmed with fish.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2018-00005 |
| MDR Report Key | 7303925 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIM GIBLIN |
| Manufacturer Street | 1910 E INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ALK |
| Product Code | PKW |
| Date Received | 2018-02-28 |
| Model Number | 06679072001 |
| Catalog Number | 790-4794 |
| Lot Number | Y13568 |
| ID Number | NA |
| Device Expiration Date | 2019-07-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |