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

Catalog Number 06C29-27

Device Problem High Test Results (2457)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

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, architect havab igg, list 6c29, that has a similar product distributed in the us, havab-g, list number 6l27.

Event Description

The customer observed (b)(6) elevated (b)(6) results on the architect i2000sr.The following data was provided: (b)(6).No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and specificity testing.A non-statistical trend was identified for increased complaints for two lots (92421li00 and 92425li00), but no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No return patient sample was available.Clinical specificity testing of negative panel replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT HAVA-B IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8137130
• MDR Text Key: 130658700
• Report Number: 3002809144-2018-00536
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 06C29-27
• Device Lot Number: 92425LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER, LN 03M74-97; LN 03M74-97 SN (B)(6) ; SN (B)(6)