MAUDE Adverse Event Report: LEICA BIOSYSTEMS NEWCASTLE LTD BOND ORACLE HER2 IHC SYSTEM; NONE

Model Number TA9145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Misdiagnosis (2159)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

A review of the results and further testing by the healthcare professional demonstrated 3 pts samples may have given a false negative result.On 23rd january 2016, (b)(4) were given the following info: pt 1: (b)(6) female, mdr number: 3004859032-2016-00001.Pt 2: (b)(6), female, mdr number: 3004859032-2016-00002.Pt 3: (b)(6), female, mdr number: 3004859032-2016-00003.Mdr 3004859032-2015-00002 was raised following the complaint.The report has been ongoing as the investigation required further info from the customer.

Event Description

(b)(4) was informed on september 14, 2015 that 2 batches of bond oracle her2 ihc system - product code ta9145 (lots 27595 and 20871) were used for testing pt samples.

• Brand Name: BOND ORACLE HER2 IHC SYSTEM
• Type of Device: NONE
• Manufacturer (Section D): LEICA BIOSYSTEMS NEWCASTLE LTD; balliol business park west; benton lane; newcastle NE12 8EW; UK NE12 8EW
• Manufacturer Contact: balliol business park west; benton lane; newcastle NE12 -8EW ; 912154736
• MDR Report Key: 5440962
• MDR Text Key: 38379017
• Report Number: 3004859032-2016-00001
• Device Sequence Number: 1
• Product Code: MVC
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TA9145
• Device Lot Number: 20871 AND 27595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR