MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT LACTIC ACID

Catalog Number 09D89-21

Device Problem Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 09/11/2016

Event Type  malfunction  

Manufacturer Narrative

Abbott laboratories identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid assay leading to falsely depressed lactic acid results.A product correction letter was issued to all current architect lactic acid customers.The letter informs the customer that patients undergoing treatment with n-acetyl cysteine (nac) may have falsely depressed lactic acid results.Architect lactic acid list number 09d89 is being discontinued.Customers who receive the final lots of list number 09d89 will be notified of the interference from nac via additional labeling (kit stuffer) contained within the reagent kit.

Event Description

The customer stated that they were made aware of a product recall from an abbott competitor regarding assay interference from n-acetyl cysteine (nac) with assays including glucose, lactic acid, uric acid and triglycerides.Upon doing research on the (b)(4), the customer found similar recalls from other competitors (beckman coulter, roche and siemens) over the past 18 months but nothing from abbott laboratories.The customer inquired as to whether abbott has any information regarding similar interference with architect assays.No discrepant architect patient results or impact to patient management was reported.

• Brand Name: ARCHITECT LACTIC ACID
• Type of Device: LACTIC ACID
• 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: 6174867
• MDR Text Key: 62467209
• Report Number: 1628664-2016-00305
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 00380740121075
• UDI-Public: 00380740121075
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09D89-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• 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: N
• Removal/Correction Number: 1628664-10/11/16-001-C
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM; LIST 03L77-01, SERIAL (B)(4)