MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-G; HEPATITIS A VIRUS IGG ANTIBODY

Catalog Number 06L27-25

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.Additional information: (b)(6) for a total of 49 samples.

Event Description

The customer provided results from 49 samples with results ranging from (b)(6) compared to (b)(6).There was no reported impact to patient management.The customer also sent 11-25 samples to a neighboring hospital to have them retested on an architect with havab-g lot 73145li00.There was no additional patient information provided.

Manufacturer Narrative

Twenty-eight potential (b)(6) samples ((b)(6) with (b)(6) hav total and (b)(6) hav igm assays) which had been tested with lot number 73336li00 or lot number 73427li00 at the customer site were sent to a neighboring hospital (b)(6) where most tested (b)(6) with lot number 73145li00.A review of the architect (b)(4) instrument logs shows high variances for (b)(6) control values with reagent lots 73336li00 and 73427li00.A review of tickets determined that there is normal complaint activity for the lot numbers and there are no trends identified for the complaint issues (specificity, sensitivity and control performance).Twenty-eight specimens were received by abbott in (b)(6) and tested with retained kits of lot numbers 73336li00 and 73427li00 and with biorad monolisatm total anti hav plus and vidas anti-hav total as reference tests.The results generated reproduced the customer's observation of (b)(6).Sensitivity and specificity testing was performed with retained kits of lot numbers 73336li00, 73427li00 (specificity and sensitivity) and 73145li00 (specificity only) and results did not indicate that the specificity or sensitivity performance of the lots is negatively impacted.Furthermore, the clinical sensitivity was evaluated by testing one commercially available seroconversion panel from biomex scp-hav-001 with lot numbers 73336li00 and 73427li00 and the lot numbers detected the same bleeds of the seroconversion panels as (b)(6) with comparable s/co values.Historical performance of the architect havab-g assay was evaluated using world wide data from abbott link.This evaluation indicated that the patient median results for lots 73336li00, 73427li00 and 73145li00 were within the established control limits and no unusual reagent performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of product labeling concluded that the issue was sufficiently addressed.Based on the investigation no product deficiency was identified for architect havab-g, lot numbers 73336li00, 73427li00, and 73145li00.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: HEPATITIS A VIRUS IGG ANTIBODY
• 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: 6945315
• MDR Text Key: 90221242
• Report Number: 3002809144-2017-00135
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2017
• Device Catalogue Number: 06L27-25
• Device Lot Number: 73145LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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