MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Model Number 14049543267

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

Event Description

On (b)(6) 2019, leica biosystems received a complaint that they experienced loss of sample during processing on their asp6025.As a result one patient had to be rebiopsied.

Manufacturer Narrative

The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site.Based on the field service engineer feedback, provided from the customer, the first three alcohols had a milky color.The milky color occurs when there is a mixture of alcohol and xylene water.This mixture was due to a user operation error; the user exchanged the processing water for xylene.Presumably the customer filled xylene in the d2 bottle instead of process water.After correcting and replacing the reagents, the equipment is operating correctly without any problem.

• Brand Name: ASP6025
• Type of Device: ASP6025
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9472005
• MDR Text Key: 184931971
• Report Number: 8010478-2019-00010
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other