MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS CONFIRM ANTI-MSH6 (44) MOUSE MONO; LYNCH SYNDROME TEST SYSTEM

Catalog Number 05929911001

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.Conclusions will be provided in a follow-up report.(b)(4).

Event Description

The customer site in (b)(6) reported a no msh6 staining (interpretation: msh6 lost b/c not stained) due to lots of background for a patient case.The case was sent to another site, per process, who performed a similar test, and msh6 stained positively (interpretation: msh6 not lost).The complaint site then performed verification with a molecular test, and they confirmed the interpretation that msh6 was not lost, so diagnosis was in tact.There is an allegation that there was a delay in the initiation of appropriate treatment to the patient, and his condition advanced.

Event Description

Additional information relating to the allegation: this sample was identified as a "cardia" biopsy and the site confirmed that the other antibodies in the mmr panel were stained (msh2, mlh1, pms2, braf).The case/patient was sent to another site for immunotherapy, where the same blocks were systematically retested on a leica instrument with an unknown msh6 antibody clone.

Manufacturer Narrative

Internal review of the slides for this case indicates that pms2 shows nicely stained internal controls with intact tumor.This slide should be compared to both the msh2 and msh6 which do not show the internal controls staining and therefore should not have been interpreted.While there is some edge artifact, the majority of the staining is seen in the cytoplasm of the glandular epithelium but none of the lymphocytes or stromal cells are staining, indicating the assay should not be interpreted and should have been repeated.It is also of note that slide label and overlay poorly adhered to the msh6 and msh2 slides which failed.Failure to properly apply the label and overlay could negatively impact slide volumes and reagent delivery across the slide.Appropriate guidance around label handling and application is available in the instrument user guides.The protocol information provided by the customer indicates that the customer is utilizing optiview dab detection, which is not included in the package insert recommendations.This cannot be ruled out as a potential contributing factor for alleged background staining.Review of the complaint data indicates that there have been no other similar cases escalated against confirm anti-msh6 (44) (05929911001) lot: e10710 in the past 24 months.No product malfunction is suspected.(b)(4).

• Brand Name: CONFIRM ANTI-MSH6 (44) MOUSE MONO
• Type of Device: LYNCH SYNDROME TEST SYSTEM
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS; 1910 e. innovation park dr.; tucson AZ 85755
• MDR Report Key: 8713836
• MDR Text Key: 148527877
• Report Number: 2028492-2019-00012
• Device Sequence Number: 1
• Product Code: PZJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2020
• Device Catalogue Number: 05929911001
• Device Lot Number: E10710
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR