MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC COMPLEMENT C3

Catalog Number 09D96-21

Device Problem Low Test Results (2458)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

This field action is associated with all lots of the following assays: architect complement c3 (ln 09d96-21) udi (b)(4), architect immunoglobulin a (ln 09d98-21) udi (b)(4), architect immunoglobulin g (09d99-21) udi (b)(4), architect immunoglobulin m (ln 01e01-21) udi (b)(4), architect apolipoprotein a1 (09d92-21) udi (b)(4), architect complement c4 (09d97-21) udi (b)(4), architect haptoglobin (09d91-21) udi (b)(4), architect apolipoprotein b (09d93-21) udi (b)(4), and architect transferrin (01e04-21 udi (b)(4), 01e04-41 udi (b)(4)).A product correction letter was issued on 16may2019 to customers who have received shipments of any of the impacted products.The letter instructs the customer to immediately discontinue the use of the edta plasma samples when using any of the impacted products.The investigation into this matter found that the edta specimen type is no longer acceptable for use with architect complement c3, architect immunoglobulin a, architect immunoglobulin g, architect immunoglobulin m, architect apolipoprotein a1, architect complement c4, and architect haptoglobin.Additionally, the specimen storage information is being revised for the architect complement c3, architect immunoglobulin a, architect immunoglobulin g, and architect immunoglobulin m assays.All reagent kits will include a kit stuffer with this information until the instructions for use (ifu) for these architect products is updated.

Event Description

Abbott identified that an update to the reagent and specimen collection and handling/preparation for analysis sections of the instructions for use (ifu) for the included architect products was required for the following issues: based on recent fibrinogen interference testing, it has been determined that edta plasma samples are no longer acceptable for use with the following assays: apolipoprotein a1 (apo a1), complement c3 (c3), complement c4 (c4), haptoglobin, immunoglobulin g (igg), immunoglobulin a (iga), and immunoglobulin m (igm).There is a potential for falsely depressed results due to fibrinogen interference with edta specimens for these products.Additionally, for the complement c4 assay, there is a potential for falsely depressed results due to fibrinogen interference with heparin tubes at the concentrations > 1512 mg/dl in lithium heparin tubes and >859 mg/dl in sodium heparin tubes.Additionally, based on recent testing, the specimen storage information is being revised for the following assays: igg, iga, igm, and c3.The maximum storage time for samples stored at 2-8 degrees c and 20-25 degrees c were inaccurately stated.These issues were identified through internal testing and no customer reports have been received to date.There have been no reported injuries as a result of these issues.

• Brand Name: COMPLEMENT C3
• Type of Device: C3
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• 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: 8671652
• MDR Text Key: 147191241
• Report Number: 1628664-2019-00371
• Device Sequence Number: 1
• Product Code: CZW
• UDI-Device Identifier: 00380740019730
• UDI-Public: 00380740019730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09D96-21
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-05/21/19-004-C
• Patient Sequence Number: 1