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

Device Problem False Positive Result (1227)

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

Event Date 08/09/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304723010
• Report Number: 1221359-2019-00079
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310106477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/27/2019
• 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
• Patient Sex: Female