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

Model Number 6L27-01

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Complete information: correction/removal reporting number
=
3002809144-11/08/19-011-r. The investigation into this issue is in process. A follow-up mdr will be submitted when the cause has been identified. A product recall letter was sent to all customers who have received shipment of the architect havab-g calibrator kit, lot 08219be00. The letter instructs the following: immediately discontinue use of the lot 08219be00 and to destroy any remaining inventory of the lot. Immediately contact customer support to order replacement material. Review the recall letter with their medical director or laboratory management and follow the laboratory protocol regarding the need for reviewing previously reported patient results. If any kits of this specific lot was forwarded to other laboratories, to notify that laboratory of the product recall and provide them a copy of the recall letter.

Event Description

Abbott laboratories has identified an issue during stability testing with the architect havab-g calibrator kit, list number 06l27-01; lot 08219be00, where this specific lot has the potential to be impacted by an increase in the relative light units (rlus) of up to 95%. With the increase in the calibrator rlu values, there is the potential for control values and patient results generated with the impacted calibrator lot to be decreased, which may change interpretations of results from reactive to falsely non-reactive. There has been no reported impact to patient management as a result of this issue.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; 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: 9376289
• MDR Text Key: 190118430
• Report Number: 3002809144-2019-00825
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/25/2020
• Device Model Number: 6L27-01
• Device Catalogue Number: 06L27-01
• Device Lot Number: 08219BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: 3002809144-11/08/19-011-