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	11/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 observed falsely elevated magnesium results on the architect c8000 analyzer.The following data was provided: initial 6.1, repeat 3.2, 1.8 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
On 12/12/2018 the suspect medical device was updated from ln 07d70-21, lot unknown to the architect c8000 analyzer, ln 01g06-11 sn (b)(4), both manufactured in the same location, irving texas usa.An evaluation is still in process.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.Replacing and calibrating the r1 probe resolved the issue.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: 8143274
• Report Number: 1628664-2018-02120
• Device Sequence Number: 19230626
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/07/2019

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: 11/24/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 02/07/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/02/2019; 02/07/2019
• 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 ANALYZER; LN 01G06-11 SN (B)(4); LN 07D70-21 LOT 33785UN18; LN 07D70-21 LOT 33785UN18; MAGNESIUM REAGENTS; MAGNESIUM REAGENTS