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

Catalog Number 06C29-27

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, specificity testing, and field data review.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Abbott link world wide data was used to evaluate historical product field performance.Patient data was analyzed the evaluation indicated that the patient median result for the complaint material was comparable to other lots in the field between november 19, 2018 and november 17, 2018.Negative population data was analyzed, and the complaint lot results were within the established limits.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified, and no product deficiency was found.This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6c27.Note, issue was already reported for lot 86040li00 under mfr report 3002809144-2018-00484.

Event Description

The customer observed falsely elevated igg antibody to (b)(6) (igg anti-hav) results while using architect havab-igg reagents.The following data was provided.Sid (b)(6): v4251 repeat using lot 80173li00 (b)(6), using lot 86040li00 initial (b)(6), repeat (b)(6).No adverse impact to patient management was reported.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8201478
• MDR Text Key: 132567435
• Report Number: 3002809144-2018-00560
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 12/27/2018

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: 09/22/2018
• Device Catalogue Number: 06C29-27
• Device Lot Number: 80173LI00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1