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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 02P24-40
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
The customer observed visible smoke accompanied with burnt plastic smell coming from the architect c4000 processing module.The instrument was then turned off.It was noted that the issue happened after the ups (uninterrupted power supply) vendor performed maintenance on the ups.The field service representative (fsr) inspected the instrument and found that the smoke came from the card cage due to a short circuit in the connection to the ac/dc board and the sensor board.The cable appeared to be charred.The damaged cable was removed and the instrument has been running with no further issue.There was no injury to the user reported.There was no impact to patient management or user safety reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
Section d4 - primary udi number: this section was corrected from (b)(4).The field service representative (fsr) inspected the instrument and discovered the source of the observed smoke and burned-plastic odor was due to a short circuit between the cables that connect the sm acdc controller board and the mech led, m 16 board.The boards and their cables were replaced to resolve the issue.An instrument service history for the architect c4000, serial #(b)(6) verifies no subsequent issues have been reported related to smoke and charred/burned parts after service intervention.A review of tracking and trending of the clinical chemistry systems did not identify any similar issues related to the architect c4000 system or the likely cause parts with regards to the current issue.The device history records were reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and found to be adequate.The 2024 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The smoke and charring/burning, observed was limited to the sm acdc controller board, mech led,m 16 board, led2 to acdc cable, led3 to sm acdc cable and led1 to smc cable, which occurred post maintenance of the uninterrupted power supply (ups) and a short circuit occurring; the smoke and charring/burning did not spread to other parts of the module.Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module, serial number (b)(6) or the likely cause parts were identified.
 
Event Description
The customer observed visible smoke accompanied with burnt plastic smell coming from the architect c4000 processing module.The instrument was then turned off.It was noted that the issue happened after the ups (uninterrupted power supply) vendor performed maintenance on the ups.The field service representative (fsr) inspected the instrument and found that the smoke came from the card cage due to a short circuit in the connection to the ac/dc board and the sensor board.The cable appeared to be charred.The damaged cable was removed and the instrument has been running with no further issue.There was no injury to the user reported.There was no impact to patient management or user safety reported.
 
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Brand Name
ARCHITECT C4000
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18723171
MDR Text Key335600740
Report Number3016438761-2024-00092
Device Sequence Number1
Product Code JJE
Combination Product (y/n)N
Reporter Country CodeGT
PMA/PMN Number
EXEMPT
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
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02P24-40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2024
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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