MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C8000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	01G06-11
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false elevated magnesium result on the architect c8000 analyzer.The initial result was greater than 8.0 mg/dl, repeated at 2.0 and 2.1 mg/dl no reported impact to patient management.
Additional Manufacturer Narrative
On may 23, 2019 the suspect medical device was changed from magnesium ln 07d70-31 lot unknown to the analyzer architect c8000 analyzer ln 01g06-11 c803650, both manufactured in irving, texas usa.An evaluation is still in process and a follow up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved by replacing the leaking peristaltic head tubing (rohs) (part number 7-35009685-02).Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT C8000 SYSTEM
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8627875
• Report Number: 1628664-2019-00392
• Device Sequence Number: 2247311
• 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: 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,Followup
• Report Date (Section B): 07/16/2019

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: 01G06-11
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/23/2019; 07/13/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 05/30/2019; 07/16/2019
• 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 C8000, LIST# 01G06-11; MAGNESIUM LN 07D70-31 LOT UNKNOWN; MAGNESIUM LN 07D70-31 LOT UNKNOWN; SERIAL # (B)(4); ARCHITECT C8000, LIST# 01G06-11; SERIAL # (B)(4)