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 Negative Result (1225)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded; single-use device.

Event Description

The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.The customer stated that patient tested with siemens atellica hiv performed on (b)(6) 2023 which generated positive results.Confirmatory testing was sent to quest diagnostics on 13mar2023 to confirm hiv results.Results pending as of (b)(6) 2023.Additional hiv test with siemens atellica reactive combo hiv was conducted on (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.B7, h6 - component code, health effect - impact code h3 other text : device discarded; single-use device.

Event Description

The customer reported three (3) false negative results with the alere determine hiv 1/2 ag/ab for multiple tests performed from (b)(6) 2023.This mfr.Report addresses test one (1) of three (3).The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.Repeat testing was performed on 11mar2023 and (b)(6) 2023 and generated negative results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results are unknown.Additional testing with siemens atellica (reactive combo) hiv was performed on (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.B7 h3 other text : device discarded; single-use device.

Event Description

The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.The customer stated that patient tested with siemens atellica hiv performed on (b)(6) 2023 which generated positive results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results pending as of (b)(6) 2023.Additional hiv test with siemens atellica reactive combo hiv was conducted on (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.H3 other text : device discarded; single-use device.

Event Description

The customer reported three (3) false negative results with the alere determine hiv 1/2 ag/ab for multiple tests performed from (b)(6) 2023 to (b)(6) 2023.This mfr.Report addresses test one (1) of three (3).The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.Repeat testing was performed on (b)(6) 2023 and (b)(6) 2023 and generated negative results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results are unknown.Additional testing with siemens atellica (reactive combo) hiv was performed on (b)(6) 2023 and (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.H3 other text : device discarded; single-use device.

Event Description

The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.The customer stated that patient tested with siemens atellica hiv performed on (b)(6) 2023 which generated positive results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results pending as of (b)(6) 2023.Additional hiv test with siemens atellica reactive combo hiv was conducted on (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

• 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: 16576813
• MDR Text Key: 311747204
• Report Number: 1221359-2023-00522
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/01/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2024
• Device Catalogue Number: 7D2648
• Device Lot Number: 213565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 07/18/2023; 07/25/2023; 07/21/2023
• Supplement Dates FDA Received: 07/17/2023; 07/18/2023; 07/25/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 81 KG