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

Catalog Number 06C29-27

Device Problem False Positive Result (1227)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information, patient identifier: multiple = 936351018140, 936351908140, 935252468140 and 930553348140.All available patient information was included.Additional patient details are not available.An evaluation is in process.A final 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 reported multiple false reactive architect havab-igg results.The samples were retested and generated non-reactive results.The following initial and retest results were provided: sample id 936351018140: 1.04 s/co and retest 0.82 s/co.Sample id 936351908140: 1.05 s/co and retest 0.24 s/co.Sample id 935252468140: 1.46 s/co and retests 0.39, 0.42, 1.20 s/co.Sample id 930553348140: 1.23 s/co and retest 0.28 s/co.No impact to patient management was reported.

Manufacturer Narrative

A review of complaint activity for the architect havab igg assay determined there is slightly elevated complaint activity for lot 03405be00.The tracking and trending report review did not identify any trends.Field data for the architect havab igg assay was reviewed as well as the performance of the likely cause lot, 03405be00.The review showed that the median and the standard deviations (sds) to cutoff of the negative population for lot 03405be00 was within established baselines.Therefore, the performance of the likely cause lot was determined to not be compromised.Manufacturing documentation was reviewed, and no issues were identified.Additionally, labeling was reviewed and sufficiently addresses the customers issue.Based on the investigation, no systemic issue or deficiency of the architect havab igg assay was identified.

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9163537
• MDR Text Key: 189496815
• Report Number: 3002809144-2019-00589
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: 06C29-27
• Device Lot Number: 03405BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-97,; ARCHITECT I2000SR ANALYZER, LN 03M74-97,; SERIAL (B)(4).; SERIAL (B)(4).