MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 04J27-32

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/18/2014

Event Type  Injury  

Manufacturer Narrative

No customer returns was available for evaluation.The ticket searches determined that there is no atypical complaint activity for the likely cause lot and the tracking and trending report review determined that there are no adverse trends and no non-statistical trends identified for the complaint issue.A review of non-conformances and deviations associated with the likely cause lot was performed and the review resulted in no occurrences that could be linked to the complaint observation.Since the issue is not related to the performance of the product, no file kit testing was performed.According to the package insert of the product, the issue is addressed in the precaution section.Based on this data and evaluation, the product is performing as intended and no product issues were identified.

Event Description

The account stated the operator accidentally dropped the sample cup with architect hiv ag/ab combo positive 3 control which splashed into the operator's lips and mouth.The operator received antiretroviral therapy of azt + 3tc.No additional operator impact was reported.

Manufacturer Narrative

This report is being filed on an international product list number 4j27 that has a similar product distributed in the u.S, list number 2p36.(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 6520 5; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3889266
• MDR Text Key: 11941536
• Report Number: 3002809144-2014-00142
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2014
• Device Catalogue Number: 04J27-32
• Device Lot Number: 35781LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4)
• Patient Outcome(s): Required Intervention