MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
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 stated that falsely elevated magnesium results were generated for five patient samples tested on the architect c4000 analyzer.No adverse impact to patient management was reported.Sid (b)(6): 3.6 mg/dl, repeat 4.7/2.4 mg/dl, sid (b)(6): 4.1 mg/dl, repeat 1.9 mg/dl, sid (b)(6): 3.3 mg/dl, repeat 1.8 mg/dl, sid (b)(6): 5.3 mg/dl, repeat 2.0 mg/dl, sid (b)(6): 9.0 mg/dl, repeat 1.4 mg/dl.
Additional Manufacturer Narrative
The suspect medical device was updated from magnesium reagent ln 07d70-21, lot 72241un19 to the architect c4000 analyzer ln 02p24-01 sn (b)(4).Both manufactured in irving, texas usa.Sections been updated to reflect the updated suspect medical device.An investigation was performed for the customer issue and included a review of complaint text, troubleshooting, a review of service history, and a review of product labeling.The field service representative (fsr) replaced the high concentration waste (hcw) pump tubing peristaltic head (rohs), which was identified as a cause and replacement resolved the issue.A review of service history on the architect analyzer showed no additional falsely depressed results after service.Review of the architect product monitoring and historical data for the tubing, peristaltic head revealed no trends, systemic issues, or related nonconformances.Labeling was reviewed and found to be adequate.No product deficiency were identified.

• Brand Name: ARCHITECT C4000 ANALYZER
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8842390
• Report Number: 1628664-2019-00535
• Device Sequence Number: 13978111
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/29/2019

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: 02P24-01
• Device Lot Number: 72241UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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 C4000 ANALYZER; LIST # 07D70-21, LOT# 72241UN19; LIST 02P24-01, SERIAL (B)(4); MAGNESIUM