MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 02P24-40

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4), no code available was selected, as some of the patient chemotherapy doses were changed.The customer stated the patients are all doing well and no adverse reactions were reported due to the medication adjustments.

Event Description

The customer observed multiple falsely depressed magnesium results while using the architect c4000 analyzer.The following data was provided (mg/ml).Patient a initial 0.9, repeat 2.0.This patient had been diagnosed with lung cancer and was being treated with genzar.A treatment adjustment of 4 g was made due to the falsely low magnesium result.Patient b initial 0.9, repeat 2.2.This patient had been diagnosed with lung cancer and was being treated with taxol.No dosage adjustments were made for this patient.Patient c initial 0.8, repeat 1.7.Diagnosis of this patient was not provided and treatment adjustment was not reported.The customer stated the patients were oncology patients and the magnesium result may dictate how much chemotherapy the patient received.Due to the initial low magnesium results, two of the patients (a and b) received increased chemotherapy, as noted above.The chemotherapy medication total doses were not provided.The customer stated the patients are all doing well and no adverse reactions were reported due to the medication adjustments.No adverse impact to patient management was reported.

Manufacturer Narrative

An abbott ambassador was dispatched to the account and found that the analyzer cuvette drying tip (part 09d51-02) was broken.The cuvette drying tip (part 09d51-02) was replaced.A precision run using magnesium quality control (qc) and patient specimens was executed and no additional erratic results were observed.The analyzer was returned to normal operation.Evaluation included a complaint text review, similar complaints review, labeling review, device history review, instrument service review, and field data review.No returns were made available from the customer site.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review for the replaced part, cuvette drying tip (part 09d51-02), did not identify any issues that may have caused the customer issue.Service history review identified no contributing factors to the customer issue.The issue was resolved through replacement of a part, cuvette drying tip (part 09d51-02).Calculated erratic rate field data was reviewed and found no systemic issues or adverse trends for the customer issue.Based on all available information and abbott diagnostics complaint investigation, no systematic issue was found and no product deficiency was identified.

• Brand Name: ARCHITECT C4000 ANALYZER
• 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: 6862434
• MDR Text Key: 86008025
• Report Number: 1628664-2017-00338
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 10/05/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CLINICAL CHEMISTRY MAGNESIUM; LIST NUMBER 07D70-21; LOT NUMBER 79865UN17