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

Catalog Number	03L77-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
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 observed magnesium imprecision on the architect c16000 system.Patient 1: initial result of <0.7 mg/dl retested at 2.7 mg/dl.Patient 2: initial result of 0.7 mg/dl retested at 2.3 mg/dl on a different analyzer.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect clinical chemistry magnesium, list 07d70-31, manufacturing site irving, texas to architect c16000 system, list 03l77-01, manufacturing site (b)(6).The customer requested service to address the issue.The abbott field service representative (fsr) performed significant troubleshooting which included replacement of multiple parts associated with quarterly maintenance, proper aspiration and dispense of reagent and sample, sample/reagent mixing, optics, cuvette wash, as well as reagent and sample pipettor wash.Although there was no single definitive cause for the discrepant magnesium results, there were no additional falsely decreased magnesium results reported after service addressed the issue.An instrument service history review revealed no additional erratic or discrepant results reported on the c1601102, nor did it identify any service or complaint issues that may have contributed to this issue.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency 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: 7647917
• Report Number: 1628664-2018-00259
• Device Sequence Number: 1405777
• Product Code: JJE
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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 C16000 SYSTEM; CLINICAL CHEMISTRY MAGNESIUM; LIST 03L77-01, SERIAL (B)(4) ; LIST 07D70-31, LOT UNKNOWN