MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGG; 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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

This issue is also being reported under mdr numbers 3002809144-2019-00866 and 3002809144-2019-00867 for two additional suspect devices, list 06c29-22, lot 01244be00 and lot 95381li00, respectively.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive havab igg results when processing on the architect i2000sr.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

This issue is also being reported under mdr numbers 3002809144-2019-00866 and 3002809144-2019-00867 for two additional suspect devices, list 06c29-22, lot 01244be00 and lot 95381li00, respectively.An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of tracking and trending data, a review of field data, review of historical data, and a review of product labeling.Ticket searches determined that there is an elevated complaint activity for lot number 01244be00 and lot number 95381li00.Tracking and trending did not identify any trends.A review of the field data of the architect havab igg assay of the past 9 months was performed, for the likely cause lots 94521li00, 95381li00 and 01244be00.This review determined the performance of the likely cause lots is not compromised.Historical specificity file kit test data for lot number 95385li00 (which contains the same bulk components as lot number 95381li00) and for lot number 01244be00 were reviewed.Retained kits of architect havab-igg reagent, list number 6c29-27, lot number 95385li00 and 01244be00 were calibrated and the calibrations met instrument specifications.All control values met control specifications and were in the typical range.Evaluation of reagent specificity determined that all values met specifications and the results were in the typical range.All generated data demonstrated that the performance of lot numbers 95385li00 and 01244be00 is not compromised.No non-conformances or deviations were identified.No systemic issue was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9315251
• MDR Text Key: 219783147
• Report Number: 3002809144-2019-00868
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Catalogue Number: 06C29-22
• Device Lot Number: 94521LI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4)