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

Catalog Number 08P07-22

Device Problem False Negative Result (1225)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity i hiv ag/ab combo result on a 75-year-old female patient whose previous result was positive.The following data was provided: (b)(6) 2023 alinity i hiv ag/ab combo result = nonreactive.Another method (dynascreen) result = negative.Another method (cleia method) result = awaiting results.Previous results: (b)(6) 2023 alinity i hiv ag/ab combo result = 23.7 s/co (reactive).Another method (cleia method) result = positive.Pcr was performed, but the results could not be confirmed.On (b)(6) 2023, the customer provided additional information.The sample was sent to the reference lab and the following results were obtained: reproducibility result = negative.Immunochromatography method = negative for both hiv-1 and hiv-2.No impact to patient management was reported.

Manufacturer Narrative

Section e1 - address 1: complete address: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, alinity i hiv ag/ab combo, list number 08p07-22, that has a similar product distributed in the us, list number 08p07-21/-31.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i hiv ag/ab combo results 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 lot numbers 49446be00 and complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lot was performed, and specifications were met which indicates the product is performing as expected.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 hiv test results provided by zeptometrix and the reagent lots detected the same bleeds as reactive for the seroconversion panels.Based on these data, it showed that the sensitivity performance of the complaint lot is not adversely affected.Based on our investigation, the alinity i hiv ag/ab combo reagent for lot 49446be00 is performing as intended, no systemic issue or deficiency was identified.

Event Description

The customer observed false nonreactive alinity i hiv ag/ab combo result on a 75-year-old female patient whose previous result was positive.The following data was provided: (b)(6) 2023 alinity i hiv ag/ab combo result = nonreactive.Another method (dynascreen) result = negative.Another method (cleia method) result = awaiting results.Previous results: (b)(6) 2023 alinity i hiv ag/ab combo result = 23.7 s/co (reactive).Another method (cleia method) result = positive.Pcr was performed, but the results could not be confirmed.On (b)(6) 2023, the customer provided additional information.The sample was sent to the reference lab and the following results were obtained: reproducibility result = negative.Immunochromatography method = negative for both hiv-1 and hiv-2.No impact to patient management was reported.

• Brand Name: ALINITY I 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: 17352951
• MDR Text Key: 319859138
• Report Number: 3002809144-2023-00317
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Catalogue Number: 08P07-22
• Device Lot Number: 49446BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI20906; ALNTY I PROCESSING MODU, 03R65-01, AI20906
• Patient Age: 75 YR
• Patient Sex: Female