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 10/12/2016

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 (b)(4) is being discontinued.Customers who receive the final lots of list number (b)(4) 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 an alert regarding several siemens assays and interference in patients treated with n-acetyl cysteine (nac).The customer inquired as to whether abbott laboratories has any concerns 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: 6133064
• MDR Text Key: 61086905
• Report Number: 1628664-2016-00290
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• 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: 11/16/2016
• 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 (B)(4), SERIAL (B)(4)