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 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, architect havab igm, list 6c30, that has a similar product distributed in the u.S., architect havab-m list 6l21.

Event Description

The customer observed a (b)(6) havab igm result on the architect i2000sr analyzer.The following data was provided: (b)(6); vidas 0.93 ((b)(6)), architect 0.11 and 0.11.(b)(6); vidas 1.07 ((b)(6)), architect 0.35 and 0.32.(b)(6); vidas 1.03 ((b)(6)), repeated on liaison as (b)(6), architect 0.88 and 0.89.(b)(6); vidas 0.58 ((b)(6)), repeated on liaison as (b)(6), architect 0.64 and 0.70.Per the package insert the interpretation of results is as follows: less than 0.80.Nonreactive (nr), 0.80 to 1.20 grayzone reactive (gz), greater than 1.20 reactive (r).There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and sensitivity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore, a retained kit of the complaint lot number, was tested in a sensitivity set-up and all control values met control specifications and were in the typical range.In addition, the clinical sensitivity was evaluated by testing one commercially available seroconversion panel.Sensitivity testing met all specifications.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: 6267879
• MDR Text Key: 65461493
• Report Number: 3002809144-2017-00002
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Catalogue Number: 06C30-25
• Device Lot Number: 70645LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2016
• 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; LN 03M74-97, SN (B)(4)