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

Model Number 1L86-01

Device Problem Leak/Splash (1354)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Field service replaced the fitting,quick disc,threaded part on the architect for resolution.A review of the architect serial i1sr51347 service history, revealed no additional issues of splashing from parts reported on the architect serial i1sr51347.No non-conformances or potential non-conformances were identified for the fitting,quick disc,threaded part.A review of the product labeling concluded that the issue is sufficiently addressed.The operations manual also addresses biological and chemical safety hazards that includes wearing personal protective equipment (ppe) and safety awareness where hazards may exist.The i1000sr service and support manual provides instructions for the removal and replacement of the fitting,quick disc,threaded part.No adverse trend was identified for the fitting,quick disc,threaded part.A review of the architect product monitoring found no adverse trend of the architect i1000sr with regards to the complaint issue.No product deficiency was identified for the complaint issue.

Event Description

The operator was splashed on intact skin above the neck when the fitting on the accumulator cap broke on the architect i1000sr.Error 5304, (vacuum system error: liquid level too high) was generated on the architect i1000sr.The operator disassembled the rear panel and observed the vacuum accumulator was half full of liquid.As soon as the operator touched the tank, one of the fittings on the cap broke and some liquid splashed which came into contact with intact skin above the neck of the operator.The operator immediately rinsed the area.No injury or medical intervention was reported.No specific patient information provided.No patient involved.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11258065
• MDR Text Key: 229601825
• Report Number: 3016438761-2021-00034
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: 00380740001537
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 01/30/2021

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: 1L86-01
• Device Catalogue Number: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1