MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. BENCHMARK ULTRA; SLIDE STAINER, AUTOMATED

Catalog Number 05342716001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: BENCHMARK ULTRA
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 e innovation park drive; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 9684687
• MDR Text Key: 178320377
• Report Number: 2028492-2020-00002
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1