MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. CONFIRM ANTI-SYNAPTOPHYSIN (SP11) RABBIT; IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Catalog Number 05479304001

Device Problem False Positive Result (1227)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

An additional kit lot was used at the customer site (f18281; expiration date: 31-jul-2021) when the high background was observed.Roche tested the retained material for confirm anti-synaptophysin (sp11) rabbit (05479304001) lot numbers f11948 and f18281 by staining slides containing normal pancreas tissue using the package insert recommended protocol on an benchmark ultra.A randomly selected confirm anti-synaptophysin (sp11) rabbit (05479304001) lot was used as control.Microscopic evaluation of the stained slides show adequate staining in the islet of langerhands cells.Strong background or aberrant staining was not observed.Confirm anti-synaptophysin (sp11) rabbit (05479304001) lot numbers f11948 and f18281 performed as intended.The customer stated that the affected confirm anti-synaptophysin (sp11) rabbit (05479304001) dispenser is staining all kinds of cells that should not stain and it is not just background staining.This information suggests possible dispenser tip contamination.(b)(4).

Event Description

Customer observed strong background staining with confirm anti-synaptophysin (sp11) lots f11948 and f18281.The erroneous positive result was reported to the requesting physician and caused a misdiagnosis.The anti-synaptophysin (sp11) was part of a panel of antibodies: cga, ki-67, p40, ttf-1, cd56, er, pr.These antibodies stained appropriately.The patient received the wrong treatment based on the anti-synaptophysin (sp11) result, which was interpreted as positive.After two months of the wrong treatment, the physician decided to retest the patient.Upon retesting, the diagnosis was changed from small cell carcinoma to metastatic carcinoma.

• Brand Name: CONFIRM ANTI-SYNAPTOPHYSIN (SP11) RABBIT
• Type of Device: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 9850188
• MDR Text Key: 192043372
• Report Number: 2028492-2020-00003
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 05479304001
• Device Lot Number: F11948
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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
• Patient Outcome(s): Required Intervention