MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT LACTIC ACID

Catalog Number	09D89-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Misdiagnosis (2159)
Date of Event	07/29/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer received a communication from roche regarding assay interference from acetaminophen (paracetamol) and its metabolites.The customer inquired as to whether abbott laboratories has any information regarding interference from acetaminophen and its metabolites including n-acetyl cysteine (nac) with architect assays including lactic acid.No discrepant architect patient results or impact to patient management was reported.

• Brand Name: ARCHITECT LACTIC ACID
• Common Device Name: LACTIC ACID
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6133234
• Report Number: 1628664-2016-00292
• Device Sequence Number: 1075222
• Product Code: KHP
• UDI-Device Identifier: 00380740121075
• UDI-Public: 00380740121075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 09D89-21
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-10/11/16-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000 SYSTEM; LIST (B)(4), SERIAL (B)(4)