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

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	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported nine (9) false positive results with the alere determine hiv-1/2 ag/ab combo test.This report represents four test (4) of nine (9) false positive (ag/ab not specified) alere determine hiv 1/2 ag/ab combo patient results reported from the customer.Confirmation testing with the abbott architect was negative/nonreactive.The patient was reported as a pregnant female.Patient sample type, treatment and outcome were unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information was not successful.This event is considered a malfunction due to unknown treatment and the risk of short and medium-term toxicity to the fetus being unknown.
Additional Manufacturer Narrative
Investigation conclusion: testing was performed at abbott diagnostics (b)(4) inc.On retained kit lot: 106477 with the following internal whole blood and serum/plasma: hiv-1 positive, hiv-2 positive, p24 positive, and hiv negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 106477 was reviewed.This lot met the required release specifications.A review of the complaints reported as false positive related to lot number 106477 showed that the complaint rate 0.008%.The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(4) inc.Was unable to determine the exact root cause of the reported issue.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that this device lot is performing within labeled claims.

• Brand Name: ALERE DETERMINE HIV-1/2 AG/AB COMBO
• Common Device Name: IVD FOR HIV 1/2 AG/AB, PRODUCT CODE
• 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: 15028494
• Report Number: 1221359-2019-00079
• Device Sequence Number: 15042296
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310106477
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: 05/28/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 106477
• 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: 12/27/2019
• Initial Report FDA Received Date: 07/15/2022
• 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