MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV-1/2 AG/AB COMBO

Catalog Number 7D2648

Device Problem False Positive Result (1227)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported a false positive result with alere determine hiv 1/2 ag/ab combo 25t on (b)(6) 2021.Repeat testing was not performed.The customer sent the same specimen to the reference lab for confirmation testing and the hiv ag result came back (b)(6).No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplemental report is being submitted to retract the previous initial mdr report for a false positive , further case review determined that this report was submitted inadvertently.This event doesn't meet the reportable criteria according to our procedures.

• Brand Name: ALERE DETERMINE HIV-1/2 AG/AB COMBO
• Type of Device: ALERE DETERMINE HIV
• 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: 13313708
• MDR Text Key: 284175257
• Report Number: 1221359-2022-00384
• Device Sequence Number: 1
• Product Code: MZF
• 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,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 7D2648
• Device Lot Number: 162948
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/16/2022
• 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