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

Catalog Number 06C30-74

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2020

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.This report is being filed on an international product, list number 6c30 that has a similar product distributed in the us, list number 6l21.

Event Description

The customer reported a false non-reactive architect (b)(6) result on a (b)(6) yr old male patient.Results provided: on (b)(6) 2020 sid (b)(6) = 0.5 s/co, wantai manual method = positive.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for a false non-reactive result for one sample tested with the architect havab igm assay lot 10346be01 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review.Inhouse retained kit testing for sensitivity could not be performed as reagent lot had been expired when complaint investigation was performed.Trending review determined no trends for the issue for the product.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on our investigation, no systemic issue or deficiency with the architect havab igm reagent lot 10346be01 was identified in the complaint.

• Brand Name: ARCHITECT HAVAB-IGM
• 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: 10566075
• MDR Text Key: 233891661
• Report Number: 3002809144-2020-00980
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: 06C30-74
• Device Lot Number: 10346BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4)
• Patient Age: 53 YR