MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number 3M74-02

Device Problem Leak/Splash (1354)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

While performing service on an architect i2000sr analyzer, the field service engineer (fse) was splashed in the eye with diluted wash buffer.The tube to the wash zone 1 heater was disconnected which splashed the diluted wash buffer in the fse¿s eye.The fse¿s eye was flushed and checked by the physician.There was no treatment given to the fse for the eye.The fse is doing well.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation for wash buffer exposure on an architect i2000sr analyzer, serial number (b)(6), included a review of information provided by the field service representative (fsr), a search for similar complaints, ticket trending review, labeling review, and device history record review.While troubleshooting the analyzer, the fsr reported being splashed in the eye with diluted wash buffer solution emerging from a disconnected tubing to the wash zone 1 heater.The fsr was inspecting the instrument without wearing protective eyewear.The fsr found the fitting of a tubing to the to the wash zone 1 heater to be popped off which caused the splashing incident.The fsr reconnected the tubing to the wash zone 1 heater; the heater, wz buffer (rohs), part number 7-78306-02, which resolved the issue.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.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 was identified.

• Brand Name: ARCHITECT I2000SR
• 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: 12706074
• MDR Text Key: 283776563
• Report Number: 3016438761-2021-00400
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: 00380740006235
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3M74-02
• Device Catalogue Number: 03M74-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1