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

Model Number 6L27-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Correction/removal number= 3002809144-03/16/20-002-r.Investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results.An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1.00 - 1.72 s/co have the potential to be falsely reactive.A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00.The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.

Event Description

The customer observed quality controls (qc) were out of range while using a new lot of the architect havab-g reagent.The customer stated that the (b)(6) qc runs were (b)(6) and the patient correlations failed.There was no reported impact to patient management.

• 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: 9880348
• MDR Text Key: 221478468
• Report Number: 3002809144-2020-00216
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 03429BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3002809144-03/16/20-002-
• Patient Sequence Number: 1