MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problems Defective Component (2292); Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The field service engineer determined the top cover was functioning without any abnormalities.Per product labeling, "cover: be careful when opening or closing a top cover.If you let go of the handle, the top cover may drop onto your fingers.Always keep a firm grip on the handle and do not let go when opening or closing a top cover.If a top cover does not stay open properly, please contact your local roche service representative." also, "open cover: injury to your head or body may be caused by an open cover.Be careful not to hit yourself when working with open covers (for example, during maintenance)." the investigation is ongoing.

Event Description

The initial reporter stated when she was troubleshooting a cobas 6000 c (501) module reagent alarm, she lost control of the top cover, and the top cover fell down and injured her pinky finger.The customer stated her finger was bent and she had iced her finger.The customer then went to the emergency room and had an x-ray.The x-ray showed the finger was fractured.The injured finger was splinted.The customer took ibuprofen and tylenol for pain.On (b)(6) 2021, the customer went to the orthopedist and it was decided that no surgery would be required.

Manufacturer Narrative

On (b)(6) 2021, the customer provided clarifying information and that she did not realize her finger was in the path of the top cover, causing her finger to be pinned between the top cover and a metal bar.She stated that the cover was being closed manually and the top cover did not lower or fall on its own.Also, the customer confirmed that she has seen an orthopedist "a couple of times" and she was released to go back to work.She stated there still is pain in her finger, but the splint helps to keep it straight.

Manufacturer Narrative

The investigation discovered the top cover that injured the customer's finger, was not designed to be used by an operator and if the top cover is opened, the handle should be used.Per product labeling, "by design, this cover is not meant to be opened or removed." the investigation determined there was no product problem.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11164938
• MDR Text Key: 230271420
• Report Number: 1823260-2021-00157
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention