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 01/03/2024

Event Type  malfunction  

Event Description

The customer reported a false negative result with the determine hiv 1/2 ag/ab combo 25t performed on or before (b)(6) 2024 on an unknown sample type.Additional testing was performed on the same day via insti kit hiv antibody test which generated a positive result.The patient was known to be hiv positive and has been receiving ¿hiv care¿ since 2016.It is unknown if the patient has been receiving antiretroviral (art) therapy.The patient is confirmed to not use biotin.Although requested, no additional information, including patient treatment and outcome, was provided.

Manufacturer Narrative

B3: the date provided is an approximation as the exact event date was not provided.D4-udi:(b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Event Description

The customer reported a false negative result with the determine hiv 1/2 ag/ab combo 25t performed on 03jan2024 on a blood sample.Additional testing was performed on the same day via insti kit hiv antibody test which generated a positive result.The patient was known to be hiv positive and has been receiving ¿hiv care¿ since 2016.It is unknown if the patient has been receiving antiretroviral (art) therapy.The patient is confirmed to not use biotin.The customer confirmed there was no harm due to the test results.Additionally, the customer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

D4-udi:(b)(4) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 794260 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: 794260, test base part number 10732998/ lot: 784893.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 794260 showed that the complaint rate is(b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.D4- corrected gtin to 00811877011101 h10-corrected udi to (b)(4)h3 other text : single use; device discarded.

Event Description

The customer reported a false negative result with the determine hiv 1/2 ag/ab combo 25t performed on (b)(6)2024 on a blood sample.Additional testing was performed on the same day via insti kit hiv antibody test which generated a positive result.The patient was known to be hiv positive and has been receiving ¿hiv care¿ since 2016.It is unknown if the patient has been receiving antiretroviral (art) therapy.The patient is confirmed to not use biotin.The customer confirmed there was no harm due to the test results.Additionally, the customer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

Additional information received: a2,a3, a5, &a6-patient information specified b2-date of occurrence specified b5-update on patient impact/treatment h6: health effect - impact code changed to f26 d4-udi(b)(4) the remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Manufacturer Narrative

D4-udi(b)(4) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 794260 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: 794260, test base part number 10732998/ lot: 784893.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 794260 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 a false negative result with the determine hiv 1/2 ag/ab combo 25t performed on (b)(6)2024 on a blood sample.Additional testing was performed on the same day via insti kit hiv antibody test which generated a positive result.The patient was known to be hiv positive and has been receiving ¿hiv care¿ since 2016.It is unknown if the patient has been receiving antiretroviral (art) therapy.The patient is confirmed to not use biotin.The customer confirmed there was no harm due to the test results.Additionally, the customer confirmed there was no delay or impact in 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: 18511270
• MDR Text Key: 333341024
• Report Number: 1221359-2024-00062
• 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,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Device Lot Number: 794260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2023
• 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: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American