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

Catalog Number 05342716001

Device Problems Unable to Obtain Readings (1516); Program or Algorithm Execution Failure (4036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

A customer from germany alleged a staining issue for one patient using the benchmark ultra instrument.The customer alleged the instrument ran a different protocol than the one given on the barcode label.An error message was received from the software.A new slide from the same patient was rerun and generated the same issue.The issue was caught by lab personnel and there was no patient impact.No harm is alleged.

Manufacturer Narrative

The investigation is ongoing.A supplemental mdr will be filed upon completion of the investigation.E1 facility name truncated due to character limit: (b)(6).

Manufacturer Narrative

The initial report stated: "a new slide from the same patient was rerun and generated the same issue." clarification was received and this should say: "the customer prepared a new slide with the same patient tissue and the slide stained normally." section h3, "device evaluation by manufacturer?" was updated.The device code was updated.The investigation showed that there were two runs executed on the same day, approximately 4 hours apart on the same slide position.Both runs had the same barcode label.The first slide run on position #29 ran to completion.Afterward, the same barcode was recycled/reused by the system.Evidence indicated that the user closed drawer #29 with the first slide in it.Next, the user created a subsequent order for which the software used the same barcode.As the first run (stained slide) remained in the drawer (position #29), the roche system read the barcode on the slide¿s label and then started running the newly associated protocol (same slide is processed twice).The issue will be addressed in the upcoming software update.There are several mitigating factors that allow the detectability of this scenario: the expected staining pattern of the intended assay, the use of the same slide and/or internal positive controls, comparison of the label to the run report which will show a protocol mismatch, and interpretation in conjunction with other relevant clinical information and assay results.

• 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 (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; na; tucson AZ 85755
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16767173
• MDR Text Key: 313568064
• Report Number: 2028492-2023-00027
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• 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
• Patient Sequence Number: 1