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

Catalog Number 04J27-77

Device Problem False Negative Result (1225)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect hiv ag/ab combo, list number 04j27-77, that has a similar product distributed in the us, list number 02p36.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive architect hiv ag/ab combo result for a female patient.The sample was retested with other methods and the results were positive.The following data was provided: (b)(6) 2023 architect hiv ag/ab combo result = 0.22 s/co (nonreactive); repeated on (b)(6) 2023 = nonreactive colloidal gold result = positive elisa result = positive no impact to patient management was reported.

Manufacturer Narrative

On (b)(6)2023, the customer provided additional information.The customer provided the result from the reference lab (cec) and the hiv result was negative.The result from the reference lab is consistent with the architect hiv ag/ab combo result.The customer is no longer questioning the architect hiv ag/ab combo results.Based upon this new information, this complaint is no longer a reportable event and no additional information will be submitted.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17151140
• MDR Text Key: 317986992
• Report Number: 3002809144-2023-00274
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Catalogue Number: 04J27-77
• Device Lot Number: 45064BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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).
• Patient Sex: Female