MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for BENCHMARK ULTRA 05342716001 manufactured by Ventana Medical Systems, Inc..
[178320377]
The failed staining was caused by one unlevel instrument specific to a customer site. The instrument was left unlevel in error after the local field service engineer performed an unrelated service action. After the completion of the service action, the local field service engineer did not level the instrument, as indicated within the level 1 (l1) operational qualification check. After the failed staining, a local application specialist went back to the site, performed the l1 operational qualification check, and determined the instrument was not level. The instrument situation was immediately addressed and the instrument is now working as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178320378]
A customer in the (b)(4) alleged that they exhausted patient tissue due to failed staining (no results) on the benchmark ultra stainer module. The site reported that none of the available slides for this patient generated results during repeat attempts. The site qcs each slide and looks for both internal negatives and positives within the control tissue. For the slides ran for this patient both the test and control were completely negative. As a consequence, the associated patient, who is suspected to have lymphoma, was not diagnosed before the ihc run, and the pathologist recommended repeating the lung biopsy as no diagnosis was determined. Although requested, there is no confirmation that the re-biopsy procedure took place and no serious injury or harm has been alleged. The failed staining was caused by an unlevel instrument used by the customer at the time of the testing. The local support organization went onsite and leveled the instrument, and now the instrument is working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2020-00002 |
| MDR Report Key | 9684687 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-07 |
| 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 | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1910 E INNOVATION PARK DRIVE NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENCHMARK ULTRA |
| Generic Name | SLIDE STAINER, AUTOMATED |
| Product Code | KPA |
| Date Received | 2020-02-07 |
| Model Number | NA |
| Catalog Number | 05342716001 |
| Lot Number | NA |
| 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 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |