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

Model Number 8100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The investigation requested the gas springs for an investigation, but the product was discarded.The issue was solved by the field service engineer replacing the gas springs.Per product labeling, "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 automatic centrifuge unit (acu) cover fell onto the customer's neck while performing maintenance on the module.No medical treatment was required.The customer confirmed the module was in "s.Stop mode" prior to opening a top cover, and all the safety instructions were followed.The next day, the field service engineer replaced the gas springs holding the acrylic cover.

• Brand Name: COBAS 8100
• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11802582
• MDR Text Key: 249949839
• Report Number: 1823260-2021-01401
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2021

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 Model Number: 8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/10/2021
• 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