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

Model Number 6L27-25

Device Problem High Test Results (2457)

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

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated (b)(6) results while using the architect (b)(6) assay.The customer provided the following results (s/co): (b)(6) 2017 sid (b)(6): initial result: 1.97 s/co and was reported out as (b)(6).The doctor sent another sample to be tested on (b)(6) 2017 ( sid (b)(6)) and generated a result of 0.47 s/co, (b)(6).Doctor called the lab and questioned the results.Both samples were pulled from storage and repeated.The sample from (b)(6) 2017 generated a repeat result of 0.70 and the sample from (b)(6) 2017 generated a result of 0.47 s/co.There was no adverse impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, in-house testing, a device history review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.A specificity testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.No systemic issue was identified which would indicate a product deficiency from the device history review.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect havab igg reagent list number 06c29, lot numbers 74119li00, was identified.

• 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: 6865207
• MDR Text Key: 87302404
• Report Number: 3002809144-2017-00126
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: (01)00380740011185(17)171019(10)74119LI00
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2017
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 74119LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1