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

Catalog Number 08P07-77

Device Problem False Negative Result (1225)

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

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section e1 phone number: (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed false negative alinity i hiv ag/ab combo results for mutliple samples.The following results were provided: initial result = 0.68 s/co, gold standard method = weak positive, autobio result = 8.0 s/co.Initial result = 0.64 s/co, and the retest result: 0.66 s/co, retested on isr60335 instrument.At another abbott user (for troubleshooting purposes only) result = 0.65 s/co.Colloidal gold = negative, autobio = 8.8 s/co, wantai = 57 s/co elisa = 50.8 s/co.Cdc western blot result = inconclusive.No impact to patient management was reported.

Event Description

The customer observed false negative alinity i hiv ag/ab combo results for mutliple samples.The following results were provided: initial result = 0.68 s/co, gold standard method = weak positive, autobio result = 8.0 s/co initial result = 0.64 s/co, and the retest result: 0.66 s/co, retested on isr60335 instrument at another abbott user (for troubleshooting purposes only) result = 0.65 s/co colloidal gold = negative, autobio = 8.8 s/co, wantai = 57 s/co elisa = 50.8 s/co.Cdc western blot result = inconclusive no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false non-reactive 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, labeling review, device history record review, and in house testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any related trends for the product for the issue.Device history record review on lot 46231be01 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house sensitivity testing was completed with lot number 46219be00 (lot number 46219be00 contains the same bulk material as 46231be01).The in-house 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 this data, it showed that the sensitivity performance of the complaint lot is not adversely affected.Based on the investigation, no systemic issue or deficiency with the alinity i hiv ag/ab combo assay for lot 46231be01 was identified.All available patient information was included.Additional patient details are not available.

• 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: 17450168
• MDR Text Key: 320297335
• Report Number: 3002809144-2023-00342
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Catalogue Number: 08P07-77
• Device Lot Number: 46231BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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, AI04929.; ALNTY I PROCESSING MODU, 03R65-01, AI04929.