MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-IGG; ARCH HAVAB

Catalog Number 06C29-22

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, device history review, field data review, and specificity testing.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The initial and repeat reactive rate of the likely cause lot was compared to other lots in the field during a 6 month period.The initial reactive rate of the complaint lot was the same as other lots in the field and the repeat reactive rate was lower than other lots in the field.The product and patient sample were not available for return.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.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.This report is being filed on an international product, list number 06c29 that has a similar product distributed in the us, list number 6l27.

Event Description

The customer observed (b)(6) patient results generated using the architect (b)(6).The following data was provided for multiple patients (s/co).(b)(6).No impact to patient management was reported.

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: ARCH HAVAB
• 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: 6523898
• MDR Text Key: 73783080
• Report Number: 3002809144-2017-00046
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2017
• Device Catalogue Number: 06C29-22
• Device Lot Number: 68250LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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 03M74-02; SERIAL NUMBER (B)(4)