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

Catalog Number 7D2648

Device Problem False Positive Result (1227)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The customer reported twenty-three (23) false positive results with the determine hiv 1/2 ag/ab tests performed on unknown dates with unknown sample types.This manufacturer's report addresses test twelve (12) of twenty-three (23) and is associated with lot# 802592 (qty 4).The customer indicated that confirmation pcr testing was performed on 1 of the 23 tests on an unknown date and generated a negative result.It is unknown if confirmation or repeat testing was performed for the other 22 results.Although requested, no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

B3: the date indicated is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.

Manufacturer Narrative

B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 802592 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 7d2648 / lot 802592 and test base part number 10732998 / lot 794332.The lot met the required release specifications.A review of the complaints reported false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 802592 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.

Event Description

The customer reported twenty-three (23) false positive results with the determine hiv 1/2 ag/ab tests performed on unknown dates with unknown sample types.This manufacturer's report addresses test twelve (12) of twenty-three (23) and is associated with lot# 802592 (qty (b)(4)).The customer indicated that confirmation pcr testing was performed on 1 of the 23 tests on an unknown date and generated a negative result.It is unknown if confirmation or repeat testing was performed for the other 22 results.Although requested, no additional patient information, including treatment and outcome, was provided.

• Brand Name: ALERE 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: 19149296
• MDR Text Key: 340905207
• Report Number: 1221359-2024-00351
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00811877011101
• UDI-Public: 010081187701110110802592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Device Lot Number: 802592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2023
• 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