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

Catalog Number	7D2648
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Please reference all related mfr.Report numbers: 1221359-2022-04501.
Event or Problem Description
The consumer reported two (2) false positive results with determine hiv 1/2 ag/ab combo performed on an an unknown date with an unknown sample.This mfr.Report addresses test results two (2) of two (2).Although requested, no additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6, h2 and h6.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177935 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 177935 and test base part number 10732998 / lot 169496.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 177935 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
• Common Device Name: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough,
• MDR Report Key: 15565673
• Report Number: 1221359-2022-04502
• Device Sequence Number: 19579394
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310177935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7D2648
• Device Lot Number: 177935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown