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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH RBM COBAS 8000; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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ABBOTT AUTOMATION SOLUTIONS GMBH RBM COBAS 8000; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Catalog Number 06Q54-01
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2023
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, product name rbm cobas 8000, list number 06q54-01, which has a same/similar component of the modular glp track system registered in the us, list number 04z96-51.
 
Event Description
The customer observed a spark in the glp track and a black spot was observed on a pcb.The module gave an unknown error message and was switched off/on and during start up, the circuit board started to smoke and burn.It was immediately turned off.During troubleshooting, the customer found an empty urine tube which may have been the cause of the short circuit.No impact to patient management / user safety was reported.
 
Event Description
The customer observed a spark in the glp track and a black spot was observed on a pcb.The module gave an unknown error message and was switched off/on and during start up, the circuit board started to smoke and burn.It was immediately turned off.During troubleshooting, the customer found an empty urine tube which may have been the cause of the short circuit.No impact to patient management / user safety was reported.
 
Manufacturer Narrative
The complaint investigation for a spark in the glp track and a black spot was observed on a pcb, included a review of information provided by the customer, a search for similar complaints, ticket trending review, labeling review, and device history record review.The field service representative (fsr) arrived on site and replaced the affected pcb rbm distribution 1 and associated 3 motor control ipos parts.The firmware was reloaded and the necessary scripts were ran onto the boards in order to resolve the issue.The abbott automation solutions (aas) technical group performed an investigation verified residue of fluid on the affected board.Further investigations with the fsr showed that the customer would remove the cover during routine use, which is not what is specified per operating procedures.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of the glp rack builder module (rbm) cobas 8000 lot glp019rbc000015 was identified.
 
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Brand Name
RBM COBAS 8000
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT AUTOMATION SOLUTIONS GMBH
sachsenkamp 5
hamburg 20097
GM  20097
Manufacturer (Section G)
ABBOTT AUTOMATION SOLUTIONS GMBH
sachsenkamp 5
hamburg 20097
GM   20097
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18221784
MDR Text Key329191930
Report Number3023268435-2023-00041
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/25/2024
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 Catalogue Number06Q54-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received11/28/2023
Supplement Dates Manufacturer Received01/15/2024
Supplement Dates FDA Received01/25/2024
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
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