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

Catalog Number 06C29-22

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.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 (b)(6) architect havab-igg results on one patient.The results provided were: sid (b)(6): initial = (b)(6) / re-centrifuged and retested = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is a trend in complaint activity for lot number 92421li00 regarding false reactive patient results.Returns were not required for testing during the investigation.Specificity testing was performed with a retained kit of lot 92421li00 and all control values met specifications and no false reactive results were obtained.Historical performance of the architect havab igg assay was evaluated using world wide data from abbottlink.The median and the standard deviations to cutoff of the negative population was within 2 sd of the overall median and the mean standard deviations to cutoff across all lot numbers.This indicates that the lot number is performing in line with all other reagent lots in the field during the reviewed timeframe.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified architect havab igg, lot 92421li00.

• 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: 8388046
• MDR Text Key: 137867790
• Report Number: 3002809144-2019-00086
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2019
• Device Catalogue Number: 06C29-22
• Device Lot Number: 92421LI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4).; SERIAL # (B)(4).