MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All the maintenance was up to date on the instrument.The customer has run precision and the quality control (qc) and the %cv results were reported to be acceptable.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Based on the available information, no product deficiency was identified.
Event or Problem Description
The customer observed falsely elevated magnesium results for three patient samples tested on the architect c16000 system.No adverse impact to patient management was reported.(b)(6) initial result 6.7 meq/l (questioned by physician) repeat 2.1 meq/l.A corrected report was issued.(b)(6) initial result >7.8 meq/l, repeat 4.35 and 4.17 meq/l.(b)(6) initial result 6.9 meq/l, repeat 2.7 meq/l.
Additional Manufacturer Narrative
Upon further review, the suspect medical device changed from the magnesium reagent to the architect c16000 system on (b)(6) 2020.An evaluation is in process for the new suspect medical device.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The abbott field service representative (fsr) performed a site visit, inspected the instrument, and resolved the issue by replacing the peristaltic pump tubing and cuvette washer nozzle.No additional magnesium discrepant result issues were reported after the service activity was completed.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.There were no additional service or complaint issues on or around the date this complaint was initiated 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 LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9405375
• Report Number: 1628664-2019-00738
• Device Sequence Number: 19673320
• Product Code: JJE
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2020

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 Expiration Date: 02/01/2020
• Device Model Number: 03P6832
• Device Catalogue Number: 03L77-01
• Device Lot Number: 69364UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 06/08/2020; 09/11/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 06/10/2020; 09/15/2020
• 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, LIST 03L77-01; LIST 03P68-32, LOT 69364UN19.; LIST 03P68-32, LOT 69364UN19.; MAGNESIUM REAGENT.; MAGNESIUM REAGENT.; SERIAL (B)(6) .