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.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• 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
• Reporter Occupation: Other Health Care 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

• Device Expiration Date: 10/23/2020
• Device Catalogue Number: 06C29-22
• Device Lot Number: 09449BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 10/27/2020 Patient Sequence Number: 1

Treatment

ARC I2000SR INST, 03M74-02, ISR53089