MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account generated a falsely elevated calcium of 5.60 mmol/l on sample id (b)(6) that repeated 2.50 mmol/l when processing on the architect c16000.The account uses a calcium reference range of 2.10 to 2.55 mmol/l.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) replaced the tbg, h.C nozzle a (rohs) because the cuvette washer nozzle 1a did not aspirate.This part is considered the likely cause of the result issue.Review of the architect serial (b)(4) service history did not identify any contributing factors on or around the date of the complaint.There was no subsequent contact from the customer regarding discrepant results.A review of a 12-month search for similar complaints did not identify an adverse trend of the tbg, nozzle a (rohs).No trends were identified for the architect c16000 and no nonconformity associated with the tbg, h.C.Nozzle a (rohs) was identified.The architect system operations manual and architect c16000 system service and support manual provides labeling with regard to component replacement, limitations of result interpretation, and troubleshooting the reported issue.Taken together, a systemic issue and/or product deficiency was not identified.

• Brand Name: ARCHITECT C16000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6802434
• MDR Text Key: 83131432
• Report Number: 1628664-2017-00317
• Device Sequence Number: 0
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1