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

Catalog Number 06C29-22

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

No customer returns were available. Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue. Complaint searches determined that there is slight elevated complaint activity for the likely cause lot. Labeling was reviewed and found to be adequate. Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified. Based on the available information, no product deficiency was identified.

Event Description

The customer observed (b)(6) architect havab-igg results while using reagent lot 01244be00. No specific data was provided. No adverse impact to patient management was reported.

• Brand Name: ARCHITECT HAVAB-IGG
• 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: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9412732
• MDR Text Key: 213688194
• Report Number: 3002809144-2019-01015
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/18/2020
• Device Catalogue Number: 06C29-22
• Device Lot Number: 01244BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown