MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP CONTROL

Catalog Number	08D06-13
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SYPHILIS TP CONTROL
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7990693
• Report Number: 3002809144-2018-00456
• Device Sequence Number: 1214273
• Product Code: LIP
• UDI-Device Identifier: 00380740103545
• UDI-Public: 00380740103545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08D06-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER, LIST # 03M74-97,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-97,; SERIAL # (B)(4); SERIAL # (B)(4)