MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 06C30-22

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer stated that results using the architect havab-igm assay have increased slightly since the customer started using new reagent lot 19112be00.Data for one sample was provided.Sample id6000059566: 0.88 s/co grayzone reactive, 0.9 s/co grayzone reactive and 0.92 s/co grayzone reactive.Grayzone range is 0.8 - 1.2 s/co.The customer received new reagent lot 19467be00 and retested the sample.The retest result was 0.6 s/co negative.The sample was tested at another laboratory and the result was positive.No adverse impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false non-reactive results for one sample tested with the architect havab igm assay 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 testing of retained kits with the complaint lot numbers.Trending review determined no adverse trend for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing of retained kits of the complaint lot number and testing of a commercially available seroconversion panel (biomex scp-hav-001) determined that the sensitivity performance is not negatively impacted.Based on the investigation, no systemic issue or deficiency with the architect havab igm reagent lot was identified.

• Brand Name: ARCHITECT HAVAB-M 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
• MDR Report Key: 10953341
• MDR Text Key: 232569335
• Report Number: 3002809144-2020-01162
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Catalogue Number: 06C30-22
• Device Lot Number: 19467BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1