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

Catalog Number 06C30-25

Device Problem Low Test Results (2458)

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

Event Date 01/15/2017

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, list number 6c30 that has a similar product distributed in the us, list number 6l21.

Event Description

The customer observed (b)(6) results while using architect havab-igm reagents.The following data was provided (s/co).(b)(6).However the specific value was not provided.Specimen collected on an unknown date was (b)(6) using siemens centaur method ((b)(6)).Architect havab-igm method results for this specimen were (b)(6), however the specific values were not provided.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, and accuracy testing.No adverse trend was identified for the customer's issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.A commercially available seroconversion panel (biomex scp-hav-001 formerly known as seroconversion panel rp-004 and distributed by (b)(4)) was tested with retained kits of the likely cause reagent lot and the complaint lot detected the same first bleeds as reactive compared to historical architect havab igm data from biomex.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.

• Brand Name: ARCHITECT HAVAB IGM
• Type of Device: IGM 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: 6305931
• MDR Text Key: 66820804
• Report Number: 3002809144-2017-00004
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2017
• Device Catalogue Number: 06C30-25
• Device Lot Number: 67390LI00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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
• Treatment: ARCHITECT I2000SR ANALYZER; LIST NUMBER 03M74-01; SERIAL NUMBER (B)(4)