MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 8100

Device Problem Mechanical Jam (2983)

Patient Problems Abrasion (1689); Unspecified Infection (1930); Laceration(s) (1946)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

The rack was stuck due to a misalignment of a rack pusher.Two hooks which push the rack forward were somehow lower on the left side, so they went underneath a rack and got stuck.The pusher was re-aligned by lifting/adjusting the hooks on the left side.The issue was resolved and the system was operational again.The investigation determined that the user did not follow instructions in product labeling for manual rack removal.The top cover was not opened when reaching into the device.The user also did not wear gloves.Product labeling states: ""-lift and remove the cover over the transport lines for filled racks.-use both hands to grasp the 5 or 10-position rack by the ends.Lift the rack upwards." the reported issue does not show a product quality issue with the cobas 8100 system.

Event Description

The initial reporter stated that a biomedical scientist was injured when trying to remove a rack from the cobas 8100 system.The injured scientist was not wearing personal protective equipment, including gloves, at the time of the event.A rack was stuck inside the reformatter module of the cobas 8100 system and the instrument could not resume operation.In order to remedy the issue, the scientist decided to stick their hand inside the rack loading lane of the reformatter in order to free the stuck rack.The top cover of the reformatter was not open at the time.When the scientist pulled their hand back from the lane, a sharp fixed hook on the upper side of the lane cut the back of the hand.The scientist went to the emergency room.At the emergency room, the scientist's wound was cleaned, disinfected, and bandaged.The wound was not deep/big enough to require stitches.There was only a surface cut on the back of the hand.Two days after the injury, the scientist got an infection in the wound and arm.The infection was treated at the emergency room and the scientist has fully recovered.The specific treatment the scientist received was requested, but not provided.The scientist was able to resume work after the injury with no reduced function in their hand.

Manufacturer Narrative

The patient code has been updated.

• Brand Name: COBAS 8100
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12266663
• MDR Text Key: 264738873
• Report Number: 1823260-2021-02259
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 07055692001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention