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

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	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported two false positive results with the determine hiv 1/2 ag/ab combo 25t on separate dates.This report is for patient one (1) of two (2).The patient, who was pregnant, received a positive result with the determine hiv 1/2 ag/ab combo 25t using a serum sample on (b)(6) 2021.An immunoassay test (siemens atellica) was performed at a third-party laboratory which generated a negative result.The baby was delivered with no complications and mother and baby were discharged.Per the customer, additional information is unavailable.
Additional Manufacturer Narrative
Investigation report: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 168386.All tests were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for kit part number kit part number 7d2648 / lot 168386 and device part number 10732998 / lot 164848.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 168386 showed that the complaint rate is 0.01 %.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.Reference related mfr.Report number 1221359-2022-03248.
Additional Manufacturer Narrative
Investigation report: the manufacturing records and quality control release testing was reviewed for kit part number: 7d2648 / lot: 168386 and device part number: 10732998 / lot: 164848.Quality control release testing met specifications and there were no false positive results observed.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).Based on the evidence available, it indicates that this device lot is performing within label claims.Abbott diagnostics scarborough tested the determine hiv-1/2 ag/ab combo retain kit: 168386 with 20 normal human serum samples from the specificity panel, and 1 of each negative nhs diluent, hiv-1, hiv-2, and p24.All positive controls were made by spiking the negative diluent.All tests were valid and performed as expected.No false positives of any kind were observed.The customer's complaint was not replicated.Tested customer returned kit, lot: 168386, with the following: 1.Hiv1-positive s/p, 2.Hiv2-positive s/p, 3.P24-positive s/p, 4.Negative s/p, 5.20 strips with 20 negative s/p.All testing was valid and performed as expected with no observations of false positive results.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: IVD FOR HIV 1/2 AG/AB
• 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: 14800412
• Report Number: 1221359-2022-03247
• Device Sequence Number: 6107905
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310168386
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/27/2022

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 Expiration Date: 02/23/2023
• Device Catalogue Number: 7D2648
• Device Lot Number: 168386
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2021
• 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 Age: 36 YR
• Patient Sex: Female