MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100 MODEL BETA WITH CRW; AUTOMATED PREANALYTICAL SYSTEM

Catalog Number 07439920001

Device Problems Mechanical Problem (1384); Unintended System Motion (1430)

Patient Problems Bruise/Contusion (1754); Concussion (2192)

Event Date 11/05/2023

Event Type  malfunction  

Event Description

We received an allegation that the open cover of the cobas 8100 fell while the user was removing samples from the automatic centrifuge unit (acu).The cover reportedly hit the user's head.The user was evaluated in the emergency department that day and was sent home with no medical intervention or treatment reported.

Manufacturer Narrative

The user alleged that she opened the cover fully before working inside the acu.The investigation is ongoing.

Manufacturer Narrative

While performing maintenance, the user accidentally bumped her head on the frame of the instrument and not on the door.The field service engineer (fse) checked the gas keys on all doors on the line and found that the gas springs (key pistons) were worn down over time.He replaced the gas springs.The fse performed a reset of the system and the system was operating within specifications.The customer resumed the operation on the instrument and ran patient samples.The root cause was due to worn gas springs.The service actions (replacing the worn gas springs) resolved the issue.No further issues were reported afterward.

• Brand Name: COBAS 8100 MODEL BETA WITH CRW
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18288043
• MDR Text Key: 330010686
• Report Number: 1823260-2023-03897
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female