MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Model Number	2P36-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Chemical Exposure (2570)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of complaints found no trends or similar issues for the complaint issue.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist.The architect hiv ag/ab package insert states that this product contains human sourced and/or potentially infectious components and should be considered potentially infectious.It is recommended that these reagents and human specimens be handled in accordance with the osha standard on bloodborne pathogens.In addition, the safety data sheet (sds) for the architect hiv ag/ab states that if the material comes in contact with the eye to rinse cautiously with water for several minutes.If eye irritation persists, get medical advice/attention.Wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.The sds documents that there is no irritant effect to eyes by the reagent.Since the user was not wearing eye protection as required per the safety instructions as outlined in the architect hiv ag/ab package insert and the safety data sheet (sds) use error contributed to the incident.Based on our investigation no product deficiency was identified for the architect (b)(6) reagent, list number 02p36.Section a patient information: no specific patient/user information was provided.
Event or Problem Description
The customer reported an employee who was splashed in the eyes with architect (b)(6) combo controls.The user was disposing of used controls when the contents of the control material splashed into the eyes.The user was not wearing protective eyewear at the time of exposure (a use error).The user is undergoing exposure treatment with prophylaxis.

• Brand Name: ARCHITECT HIV AG/AB COMBO REAGENT KIT
• Common Device Name: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10837156
• Report Number: 3002809144-2020-01110
• Device Sequence Number: 3595243
• Product Code: MZF
• UDI-Device Identifier: 00380740003890
• UDI-Public: 00380740003890
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: 2P36-25
• Device Catalogue Number: 02P36-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention