MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM

Model Number 8100

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Headache (1880); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521); Muscle/Tendon Damage (4532)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi): (b)(4).The field service engineer (fse) found an issue with the lid gas springs and replaced them.After replacing the lid gas springs the cover remained open.The gas springs were requested for investigation, however, they were discarded by the fse.The investigation is ongoing.Product labeling states: "injury due to top cover dropping suddenly.Be careful when opening or closing a top cover.If you let go of the handle, the top cover can drop onto your fingers, or any other body part inside the instrument.If you do not fully open a top cover during maintenance, it can drop onto any body part inside the module.Always keep a firm grip on the handle and do not let go when opening or closing a top cover.Always open the top cover fully before starting work inside a module.If a top cover does not stay open properly, contact your local roche service representative.".

Event Description

The initial reporter stated the cover of the automatic centrifuge unit (acu) hit a technician¿s head while they were reaching into the module.The technician was retrieving a tube.The reporter stated the cover was opened, but it doesn¿t stay open.The technician complained of a headache and went to the occupational health clinic.The technician was seen at the clinic on (b)(6) 2021 for "strain of muscle facia and tendon at neck level and other muscle spasm." the technician was prescribed unspecified medication and was asked to follow up on 11-jun-2021 but did not show up.The technician received no work restrictions, lost no time at work and is currently back at work.The technician was referred to physical therapy.Additional information related to the specific treatment received and the technician¿s current condition was requested but was not provided.

Manufacturer Narrative

The field service representative (fsr) confirmed that during the last service activities performed between (b)(6) 2021 and (b)(6) 2021 the acrylic cover stayed up when pushed all the way up.The customer also confirmed the acrylic cover stayed open when pushed all the way up.The customer stated they had always opened the lids and worked inside the module with no issues until this event.A weak or damaged gas spring could not be confirmed as the gas springs were not available when requested for investigation.Product labeling states: "always open the top cover fully before starting work inside a module.If a top cover does not stay open properly, contact your local roche service representative." the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 8100
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12044732
• MDR Text Key: 257759516
• Report Number: 1823260-2021-01795
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other