MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 01L86-40

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The customer reported the architect i1000sr analyzer shut itself off after the customer heard a bunch of popping sounds, then a burning smell, and then noticed smoke around the instrument.Abbott field service engineer onsite: scc, cpu power supply appeared to have a bulged capacitor with notable signs of melting.No impact to patient management or user safety was reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported the architect i1000sr analyzer shut itself off after the customer heard a bunch of popping sounds, then a burning smell, and then noticed smoke around the instrument.Abbott field service engineer onsite: scc, cpu power supply appeared to have a bulged capacitor with notable signs of melting.No impact to patient management or user safety was reported.

Manufacturer Narrative

During the subsequent site visit by the field service engineer (fse) the analyzer was inspected, and the power supply scc-e platform was replaced which showed evidence of melting/charring.The charring did not spread to other parts of the analyzer.A review of the analyzer service history and logs identified no contributing factors to the current complaint.There have been no further occurrences since the site visit by the fse.The architect operations manual contains adequate information for troubleshooting the observed issue.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of the immunoassay platforms tracking and trending data revealed no systemic issues or trends with regards to the current issue.The 2023 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.Based on the investigation no systemic issue or deficiencies were identified.

• Brand Name: ARCHITECT I1000SR
• 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 Key: 18776133
• MDR Text Key: 336184553
• Report Number: 3016438761-2024-00115
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01L86-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1