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

Catalog Number 04J27-89

Device Problem False Negative Result (1225)

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

Event Date 10/29/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 - phone number complete entry = (b)(6).Section e1 - address 1 complete entry = (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a false non-reactive architect hiv ag/ab result generated on a 28-year-old pregnant female patient sample.The following data was provided (reference range <1.00 is non-reactive): colloidal gold initial = positive, then tested on the architect and result = 0.23 s/co, sample centrifuged and retested.Result = non-reactive.Repeat colloidal gold = positive, and negative.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing of a retained reagent kit.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review for lot 54530be00 did not identify any non-conformances or deviations with the complaint lot.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false reactive results were obtained, indicating that the lot generates the expected results.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels.The lot detected the same bleeds as reactive for the seroconversion panels, which indicates the sensitivity performance of the complaint lot is not negatively affected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect hiv ag/ab reagent lot number 54530be00, was identified.

Event Description

The customer observed a false non-reactive architect hiv ag/ab result generated on a 28-year-old pregnant female patient sample.The following data was provided (reference range <1.00 is non-reactive): colloidal gold initial = positive, then tested on the architect and result = 0.23 s/co, sample centrifuged and retested.Result = non-reactive.Repeat colloidal gold = positive, and negative.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: 18110349
• MDR Text Key: 328024100
• Report Number: 3002809144-2023-00464
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Catalogue Number: 04J27-89
• Device Lot Number: 54530BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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)