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

Catalog Number 01G06-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer generated elevated magnesium results while using the architect c8000 analyzer.The customer provided the following data (customer normal range 1.6-2.6 mg/dl): initial 7.5, retest 1.9 and 2.9.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint data, a service history review, a search for similar complaints, and a review of labeling.Replacement of the probe was completed and no additional discrepant results have been generated.A service history review found no contributing factors on or around the date of the complaint.Tracking and trending did not identify an adverse trend related to discrepant magnesium results.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect c8000 analyzer, list number 01g06, was identified.

• Brand Name: ARCHITECT C8000 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: 5191250
• MDR Text Key: 30363131
• Report Number: 1628664-2015-00270
• Device Sequence Number: 0
• Product Code: JGJ
• 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: 11/17/2015

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: 01G06-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2006
• 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