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

Catalog Number 06C29-22

Device Problem False Positive Result (1227)

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

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Completed information: (b)(6).No further patient information was provided by the customer.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, list number 6c29 that has a similar product distributed in the us, list number 6l27.

Event Description

The customer observed false reactive architect havab-igg results for multiple samples.Additionally, the customer reported inconsistent values for the assay between their two architect analyzers (serial numbers (b)(4)) including the control material.The customer completed a weekly repeat of the following sample on both analyzers.The customer believes the samples were stored correctly prior to the repeat testing.It is unknown which analyzer generated the initial results (units of measure = s/co, reference range: greater than or equal to 1.0 s/co = reactive): (b)(6) 2020; sid: (b)(6) original result = 0.83, repeats on isr53089 = 0.83, 1.00, and 1.03, repeats on isr53090 = 0.85, 0.86, and 0.88 no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive 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 field data review of the complaint lot number.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on lot 09449be00 did not show any potential non-conformances or deviations.The overall performance of architect havab igg reagents in the field was reviewed using field data and suggested that the performance is acceptable.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation, no systemic issue or deficiency with the architect havab igg for reagent lot 09449be00 was identified.Section d4 expiration date was corrected from 10/23/2020 to 08/23/2020.Section h4 device mfg date was correct from 11/11/2019 to 10/7/2019.

• Brand Name: ARCHITECT HAVAB-G 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: 10738705
• MDR Text Key: 213176305
• Report Number: 3002809144-2020-01054
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Catalogue Number: 06C29-22
• Device Lot Number: 09449BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, ISR53089