MAUDE Adverse Event Report: LEICA BIOSYSTEMS NEWCASTLE LTD. LEICA BIOSYSTEMS; BOND ORACLE HER2 IHC SYSTEM

Catalog Number TA9145

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2015

Event Type  malfunction  

Event Description

Leica biosystems (b)(4) received a complaint to state bond oracle her2 ihc system ta9145 batch 30140 to state the following: "there is a lot more background staining than usual and not as crisp as it used to be.Also, the membranous "chicken wire staining is not continuous, it appears broken up".This resulted in the re biopsy of 3 patients.The product has been requested to be returned for analysis.

Manufacturer Narrative

This product is to be returned to leica biosystems newcastle ltd to perform testing.The retained unit has been tested according to the ifu/dmr, no issues were observed when testing w/known positive control samples, both tissue and cell lines (cell lines are provided with the oracle kit).No further actions at this time until the customer unit has been returned for testing.

Manufacturer Narrative

The customer have confirmed they have destroyed the unit therefore, further testing could not be performed.The retained unit had been tested according to the ifu/dmr, no issues were observed when testing with known positive control samples, both tissue and cell lines (cell lines are provided with the oracle kit).

• Brand Name: LEICA BIOSYSTEMS
• Type of Device: BOND ORACLE HER2 IHC SYSTEM
• Manufacturer (Section D): LEICA BIOSYSTEMS NEWCASTLE LTD.; balliol business park west; benton lane; newcastle upon tyne NE12 8EW; UK NE12 8EW
• Manufacturer Contact: natalie henderson ; balliol business park west; benton lane; newcastle upon tyne ; UK ; 912154736
• MDR Report Key: 5249572
• MDR Text Key: 32363830
• Report Number: 3004859032-2015-00003
• Device Sequence Number: 1
• Product Code: MYA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2016
• Device Catalogue Number: TA9145
• Device Lot Number: 30140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other