MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION

Catalog Number 7D2648

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Please reference: 1221359-2022-05080 - 1221359-2022-05089.

Event Description

The customer reported ten (10) false positive results with the determine hiv 1/2 ag/ab combo 25t on unknown dates.This report is for patient three (3) of ten (10).The patient tested positive with the determine hiv 1/2 ag/ab combo however confirmation testing (unknown brand and platform) generated a negative result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6 and h2.The customer was unable to provide the required intake information.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• Brand Name: DETERMINE HIV 1/2 AG/AB COMBO 25T
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 15508829
• MDR Text Key: 303393497
• Report Number: 1221359-2022-05082
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1