MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT VALPROIC; IVALPROIC ACID

Catalog Number	01P35-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a.Patient information, patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false decreased ivalproic acid results when processing on the architect i2000sr.The initial result for (b)(6) was greater than 150 (209.639 ug/ml).Retest after dilution was 77.40 ug/ml.Retest result of the diluted sample was 78.29 ug/ml.The sample was tested undiluted and the result was greater than 150 and this sample was diluted and generated a result of 40.98 ug/ml.Additional testing using gaschromatography generated a result of 75.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a device history record review, testing using a retained kit, and a review of product labeling.Review of the ticket trending and lot search did not identify an increase in complaint activity related to the complaint issue.A device history record review was performed on architect ivalproic acid reagent lot 02081lp43, which did not show any potential non-conformances, deviations or non-conformances.Accuracy testing was performed to evaluate architect ivalproic acid reagent lot 02081lp43, using a retained kit of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT VALPROIC
• Common Device Name: IVALPROIC ACID
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9150292
• Report Number: 1415939-2019-00203
• Device Sequence Number: 13986146
• Product Code: LEG
• UDI-Device Identifier: 00380740001827
• UDI-Public: 00380740001827
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2020
• Device Catalogue Number: 01P35-25
• Device Lot Number: 02081LP43
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR ANALYZER, LN 01L87-97,; SERIAL (B)(4)