MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP CONTROL

Catalog Number 08D06-13

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.

Event Description

The customer reported that a male employee dropped a sample cup with architect (b)(6) control in it and some of the fluid splashed into his eye.The employee flushed his eye with water.The employee saw his physician but no additional treatment was given.The employee was not wearing any personnel protective eye wear.There was no reported impact to employee management.

Manufacturer Narrative

A review of the complaint text showed that the user injury is related to user error, since the user did not wear safety glasses when the issue occurred.The tracking and trending review determined that there are no trends identified for the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Since the issue occurred by use error and is not related to the performance of the product, no file kit testing is required.A review of labeling concluded that the issue is adequately addressed.Additionally, the following is provided in the safety data sheet for the architect syphilis tp negative control 3 (ln 8d06-13; component 8d06l), section 8.2 exposure controls: eye protection - wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.Based on the investigation, we have determined that there is no issue with the architect syphilis tp negative control, use error may have contributed to the customer's issue.

• Brand Name: ARCHITECT SYPHILIS TP CONTROL
• Type of Device: SYPHILIS TP CONTROL
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7990693
• MDR Text Key: 126221471
• Report Number: 3002809144-2018-00456
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740103545
• UDI-Public: 00380740103545
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08D06-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-97,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-97,; SERIAL # (B)(4); SERIAL # (B)(4)