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

Catalog Number 01G06-11

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that an initial elevated magnesium result of > 3 mmol/l was generated on the architect c8000 analyzer.The sample was repeated and a result of 0.71 mmol/l was generated.There was no report of impact to patient management.

Manufacturer Narrative

An elevated magnesium result was generated by the architect c8000 analyzer.An abbott field service representative (fsr) was dispatched to the account.Upon inspection of the architect c8000 analyzer it was determined that the sample probe tubing was not secure.The fsr reseated the sample probe tubing and performed syringe maintenance.Review of instrument service history revealed no additional occurrences of erratic / discrepant results or any additional service or complaint issues that may have contributed to this issue.Customer complaint data was reviewed and no systemic or adverse trends were identified.The architect system operations manual was reviewed and provides adequate information, troubleshooting, maintenance and component replacement procedures concerning erratic / discrepant results.The investigation did not identify a malfunction / deficiency.

• 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: 5238006
• MDR Text Key: 31835781
• Report Number: 1628664-2015-00299
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: CA
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

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: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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