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

Catalog Number 7D2648

Device Problem False Positive Result (1227)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before (b)(6) 2022.This mfr.Report is four (4) of four (4) and lot number 164848.The quantity of false results per lot number was not provided.Confirmation testing via pcr performed at a third-party lab (platform: unknown) generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.

Manufacturer Narrative

The date provided is an estimate as the exact date of occurrence was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single-use; device discarded.

Manufacturer Narrative

The date provided in b3 is an estimate as the exact date of occurrence was not provided.Further information was received from the customer, it was determined that those receiving a false positive result were either male or a non-pregnant female patient.As such, the risk of a serious adverse event is low and not likely to cause a death or serious injury.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use; device discarded.

Event Description

The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before (b)(6) 2022.This mfr.Report is four (4) of four (4) and lot number 168386.The quantity of false results per lot number was not provided.The customer stated a blood sample was tested from a fingerstick.Confirmation testing via pcr performed at a third-party lab (platform: unknown) on an intravenous blood sample generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.

Manufacturer Narrative

Additional information: d4 (exp date).Investigation conclusion: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot: 168386 with positive quality control samples and internal negative quality control samples.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: 168386, 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 (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H3 other text: single-use; device discarded.

Event Description

The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before on (b)(6) 2022.This mfr.Report is four (4) of four (4) and lot number: 168386.The quantity of false results per lot number was not provided.The customer stated a blood sample was tested from a fingerstick.Confirmation testing via pcr performed at a third-party lab (platform: unknown) on an intravenous blood sample generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
• Type of Device: 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: 15888240
• MDR Text Key: 304682953
• Report Number: 1221359-2022-10206
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00811877011101
• UDI-Public: 00811877011101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2021
• 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