• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11802582
MDR Text Key249949839
Report Number1823260-2021-01401
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number8100
Device Catalogue Number07439920001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2021
Initial Date FDA Received05/10/2021
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 Number1
-
-