MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HAVAB IGM REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 02R28-22

Device Problem False Negative Result (1225)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6).All available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).This report is being filed on an international product, list number 02r28, that has a similar product distributed in the us, list number 08p28.

Event Description

The customer observed false nonreactive alinity i havab igm results for one patient.The following data was provided (<0.80 s/co is nonreactive): sample id (b)(6).Initial result, on (b)(6) 2023, was 0.56 s/co.The patient was recollected, on (b)(6) 2023, under sample id (b)(6), and the result was 0.46 s/co.The patient was tested for havab igm at another laboratory on (b)(6) 2023, with a roche anti-hav igm assay, and the result was positive.The sample was also tested at another laboratory and the result was negative.Additional laboratory results were provided: havab igg result on (b)(6) 2023 was 0.33 s/co, havab igg result on (b)(6) 2023 was 0.44 s/co.The rna-pcr havab result was positive on (b)(6) 2023.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i havab igm 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 of a retained kit of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 49245be00, stored at the recommended storage condition.Testing of a seroconversion panel (biomex scp-hav-001) showed that the reagent detected the same first reactive bleed with comparable s/co values for the seroconversion panel.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i havab igm reagent, lot number 49245be00, was identified.

Event Description

The customer observed false nonreactive alinity i havab igm results for one patient.The following data was provided (<0.80 s/co is nonreactive): sample id (b)(6) initial result, on (b)(6) 2023, was 0.56 s/co.The patient was recollected, on (b)(6) 2023, under sample id (b)(6) , and the result was 0.46 s/co.The patient was tested for havab igm at another laboratory on (b)(6) 2023, with a roche anti-hav igm assay, and the result was positive.The sample was also tested at another laboratory and the result was negative.Additional laboratory results were provided: havab igg result on (b)(6) 2023 was 0.33 s/co, havab igg result on (b)(6) 2023 was 0.44 s/co.The rna-pcr havab result was positive on (b)(6) 2023.There was no impact to patient management reported.

• Brand Name: ALINITY I HAVAB IGM REAGENT KIT
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 17664718
• MDR Text Key: 322447016
• Report Number: 3002809144-2023-00378
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Catalogue Number: 02R28-22
• Device Lot Number: 49245BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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, AI24469; ALNTY I PROCESSING MODU, 03R65-01, AI24469