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

Catalog Number 01G06-11

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).The patient received iv fluids.Concomitant medical products and therapy dates ict diluent ln 02p32-11 ln 79765un18, cc creatinine ln 03l81-32 ln 79769un18 architect c16000 analyzer ln 3l77-01 sn (b)(4).

Event Description

The customer observed erratic potassium and creatinine results while using the architect c8000 analyzer.The following data was provided for the same patient.Potassium (k) (normal range 3.5 to 5.1 mmol/l): sid (b)(6) (first draw) using analyzer sn (b)(4) initial 7.8 mmol/l, repeat 5.3, 5.5 mmol/l; sid (b)(6) (second draw) initial using analyzer sn (b)(4) 3.8 mmol/l, repeat using analyzer sn (b)(4) 3.7 mmol/l.Creatinine (crea) (normal range 0.72 to 1.25 mg/dl): sid (b)(6) (first draw) using analyzer sn (b)(4) initial 6.08 mg/dl, repeat 2.80, 3.22 mg/dl; sid (b)(6) (second draw) initial using analyzer sn (b)(4) 0.82 mg/dl, repeat using analyzer sn (b)(4) 0.82 mg/dl.The patient was in the emergency room (ed) and received iv fluids between the draws of the first and second specimens to reduce the potassium levels and creatinine.Impact to patient health was unknown.

Manufacturer Narrative

The customer had tightened the screw on the analyzer mixer [part 09d59-02], however the customer replaced the mixer to address the issue.No additional discrepant results generated the analyzer after the mixer was replaced.This was determined to be the likely cause for the issue.Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument service review, and labeling review.Returns were not available.No adverse trend was identified for the customer issue.Device history review for part did not identify any issues that may have caused the customer issue.Analyzer service history was reviewed and no contributing factors were found.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Section 11.Concomitant medical products ict diluent ln 02p32-11 ln 79765un18 cc creatinine ln 03l81-32 ln 79769un18 architect c16000 analyzer ln 3l77-01 sn (b)(4).

• Brand Name: ARCHITECT C8000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7660835
• MDR Text Key: 113504317
• Report Number: 1628664-2018-00264
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: 00380740000509
• Combination Product (y/n): N
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR