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

Catalog Number 04J27-37

Device Problem Leak/Splash (1354)

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

Event Date 02/03/2023

Event Type  malfunction  

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.This report is being filed on an international product, list number 04j27-37, that has a similar product distributed in the us, list number 02p36.

Event Description

The customer reported that while preparing the hiv ag/ab combo control material, they noticed a few drops of control material splashed on their face.The customer washed their face with plenty of water.The customer did not receive any treatment for the exposure.It was noted that the customer will be tested for hiv ag/ab once a week.There was no adverse impact to the user reported.

Manufacturer Narrative

The complaint investigation for architect hiv ag/ab combo quality control exposure included a review of information provided by the customer, a search for similar complaints, ticket trending review, labeling review, and device history record review.While preparing the hiv ag/ab combo control material, they noticed a few drops of control material splashed on their face.The customer washed their face with plenty of water.The customer did not receive any treatment for the exposure.No subsequent issues have been reported.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the issue.Based on the information provided and abbott diagnostics¿ complaint investigation, the architect hiv ag/ab combo is performing as intended at the customer site, and no systemic issue or deficiency was identified.Concomitant product section updated to correct the hiv control lot number.

• Brand Name: ARCHITECT HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16368778
• MDR Text Key: 309521554
• Report Number: 3002809144-2023-00085
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N/A
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 04J27-37
• Device Lot Number: 43120BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC HIV AG/AB CTL, 04J27-12, 40378BE00.; ARC I2000SR INST, 03M74-02, (B)(4).; ARC I2000SR INST, 03M74-02, (B)(4).; HIV AG/AB CMB CTL, 06L24-10, 46400BE00.