MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	03L77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer generated a falsely elevated magnesium result while using the clinical chemistry magnesium assay on the architect c16000 analyzer.The customer provided the following result data: sid (b)(6): initial 8.6 mg/dl, retest 1.7 mg/dl.No impact to patient management was reported.No additional patient information was provided.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint data, troubleshooting by abbott field service, review of service history, a search for similar complaints, and a review of labeling.Return material was not available.The abbott field service representative (fsr) evaluated the analyzer.The fsr cleaned multiple parts, performed internal decontamination and replaced parts (tubing, nozzles, bellows and probes.) no additional reports of false elevated magnesium results have been received on the analyzer after the fsr evaluation.An instrument service history review verified no subsequent issues have been reported since service visit and the customer moving the magnesium reagent to a different line.A review of historical data for the architect c16000 system revealed no adverse trend, systemic issues, or nonconformance.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect c16000 analyzer, list number 03l77, was identified.

• Brand Name: ARCHITECT C16000 SYSTEM
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8059823
• Report Number: 1628664-2018-02005
• Device Sequence Number: 19184083
• Product Code: JJE
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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 Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/20/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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: CLINICAL CHEMISTRY MAGNESIUM ASSAY; CLINICAL CHEMISTRY MAGNESIUM ASSAY; LN 07D70-31, LOT 99662UN18; LN 07D70-31, LOT 99662UN18