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	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Reference mfr number - 1221359-2022-04379.
Event or Problem Description
The customer reported two (2) false positive results with the determine hiv 1/2 ag/ab combo 25t for two patients performed on various dates.This mfr.Report addresses patient 2 of 2.The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo 25t test on (b)(6) 2022.Confirmatory testing at lab corp was not performed due to specimen issue.Also customer confirmed patient was pregnant and test was performed before delivery.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 175684 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 175684 and test base part number 10732998 / lot 166383.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 175684 showed that the complaint rate is 0.00482%.In conclusion, 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, ME 04074 ; 6613888803
• MDR Report Key: 15348145
• Report Number: 1221359-2022-04380
• Device Sequence Number: 12070041
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310175684
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/14/2022

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: Lay User/Patient
• Device Catalogue Number: 7D2648
• Device Lot Number: 175684
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/14/2022
• 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: Female