MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Catalog Number 04J27-84

Device Problem False Negative Result (1225)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive architect hiv ag/ab combo results for one patient who tested positive by another method.The samples were retested, and the results remained nonreactive.The following data was provided: on (b)(6) 2023 architect hiv ag/ab combo result= nonreactive; repeat result= nonreactive.On (b)(6) 2023 architect hiv ag/ab combo result= nonreactive; repeat result= nonreactive.On (b)(6) 2023 roche result= positive.No impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 04j27-84 (architect hiv ag/ab combo) that has a similar product distributed in the us, list number(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false nonreactive architect hiv ag/ab combo result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot number and complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the lot 56082be00 was performed.All specifications were met, and no false nonreactive results were obtained, showing that the lot generates the expected results.In addition, the clinical sensitivity was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9013 and hiv 9016).The seroconversion panel results were compared to architect hiv test results provided by zeptometrix and the reagent lot detected the same bleeds as reactive.Based on these data, it was shown that the sensitivity performance of the lot is not adversely affected.Based on our investigation, no systemic issue or deficiency with the architect hiv ag/ab combo reagent for lot 56082be00 was identified.The following sections have been corrected to reflect the current contact (b)(6).

Event Description

The customer observed false nonreactive architect hiv ag/ab combo results for one patient who tested positive by another method.The samples were retested, and the results remained nonreactive.The following data was provided: (b)(6) 2023 architect hiv ag/ab combo result = nonreactive; repeat result = nonreactive.(b)(6) 2023 architect hiv ag/ab combo result = nonreactive; repeat result = nonreactive.(b)(6) 2023 roche result = positive.No impact to patient management was reported.

• Brand Name: ARCHITECT HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17716892
• MDR Text Key: 323898280
• Report Number: 3002809144-2023-00389
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: 05/03/2024
• Device Catalogue Number: 04J27-84
• Device Lot Number: 56082BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/10/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).