MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-G; IGG ANTI-HAV

Catalog Number 06C29-22

Device Problem False Positive Result (1227)

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

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect havab-igg, list 6c29, that has a similar product distributed in the us, havab-g, list number 6c27.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no further patient information was provided.Patient identifier: multiple = (b)(6).

Event Description

The customer reported multiple (b)(6) architect havab-igg results.The following results were provided: on (b)(6) 2019, (b)(6).No further information was provided and no impact to patient management was reported.

Manufacturer Narrative

A review of the complaint records for lot numbers 94521li00 and 95381li00 did not identify any problems related to false reactive results.Tracking and trending report review for the architect havab igg assay determined that there are no related adverse or non-statistical trends.Using worldwide field data the performance of reagent lots 94521li00 and 95381li00.The median and standard deviation to cutoff values of the negative population were within the established limits of the architect havab igg assay.Therefore, no unusual reagent performance was identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect havab igg assay was identified.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8396124
• MDR Text Key: 138148878
• Report Number: 3002809144-2019-00088
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Catalogue Number: 06C29-22
• Device Lot Number: 95381LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02.; ARCHITECT I2000SR, LIST 03M74-02.; SERIAL (B)(4).; SERIAL (B)(4).