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

Catalog Number 02P24-01

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account generated a falsely depressed magnesium of 0.3225 mmol/l on sample id (b)(6) that also generated magnesium of 0.8029, 0.8787, 0.7890 mmol/l on the architect c4000.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

A review of the architect c4000 serial (b)(4) abbottlink logs found no relevant messages in the history log and quality control results were within specifications.The architect c4000 serial (b)(4) service history includes several instances of inconsistent high magnesium results which were investigated by abbott.Instrument related troubleshooting has included log analysis, performing maintenance and replacing, cleaning and adjusting various parts.No adverse trends were identified in a review of ticket trending data for the magnesium assay.A review of architect c4000 tracking and trending data in the product monitoring review revealed no systemic issues or adverse trends associated with magnesium results.The architect c4000 erratic result rate is within acceptable limits with no trends identified.The architect system operations manual provide information with regard to specimen handling, maintenance, and troubleshooting the reported issue including numerous probable causes and corrective actions.A specific cause for the intermittent magnesium fliers has not been identified.The recurrent issue has been addressed with troubleshooting provided in the architect system operations manual, customer service and support and field service.The architect c4000 analyzer is performing acceptably.

Manufacturer Narrative

Concomitant product(s), was updated from magnesium list 07d70-20 to the correct magnesium list 03p68-21.

• 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: 5036881
• MDR Text Key: 25144512
• Report Number: 1628664-2015-00222
• 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: Health Professional
• Type of Report: Followup
• Report Date: 11/10/2015

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: 02P24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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