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 Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No consequences or impact to patient; a follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that the architect analyzer generated falsely elevated magnesium (mg) results on one patient.Results provided: initial mg = 3.0 / repeat sample = 1.2mg/dl (normal range 1.6-2.6mg/dl).There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

An evaluation was performed by reviewing the complaint text, other customer complaints for similar issues, a review of labeling, and a review of historical data.The customer observed falsely elevated magnesium results generated for one patient sample on the architect c8000 (serial number (b)(4)).The field service representative (fsr) resolved the issue by cleaning the cuvettes (segment, cuvette assy, complete (list number (b)(4))).Review of the service history for this instrument revealed no subsequent complaints of discrepant/erratic results.A review of complaints did not identify any trend or similar complaints for this issue.A review of labeling shows adequate information is provided regarding troubleshooting of the described issue.Based on the results of this investigation, there is no indication of a deficiency or malfunction of either the architect (b)(4)or the cuvettes ((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
• 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: 5165267
• MDR Text Key: 29045259
• Report Number: 1628664-2015-00260
• 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: 11/09/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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