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	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a.Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false elevated magnesium result generated on the architect c16000.The following data was provided: sid (b)(6) initial result = 6.19 mg/dl, repeat = 2.42 mg/dl.Magnesium package insert normal range = 1.6 to 2.6 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The suspect medical device was changed from magnesium, list 03p68-21, lot 69367un19 to architect c16000 analyzer, list 03l77-01, serial (b)(6) on (b)(6) 2019.Abbott field service (fs) performed on site-troubleshooting and performed maintenance which included adjusting and cleaning various parts of the architect (b)(6).The vacuum pump and sample probe was determined to be the likely cause.A review of the (b)(6) instrument service history found no additional likely causes and no additional reports of discrepant or inconsistent results have been received since fs addressed the issue.A review of historical data for the vacuum pump and sample probe did not identify any trends or systemic issues.A review of tracking and trending for the clinical chemistry systems revealed that the calculated rates for the architect c4000, c8000, and the c16000 systems were all below the upper control limit and no trends were identified for the current complaint.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c4000, serial number (b)(6), the vacuum pump, or the sample probe 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: 8745841
• Report Number: 1628664-2019-00470
• Device Sequence Number: 10835263
• Product Code: JJE
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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
• Device Lot Number: 69367UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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 C1600, SERIAL (B)(6).; LIST 03P68-21.; LIST 3L77-01.; MAGNESIUM, LOT 69367UN19.