MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem High Test Results (2457)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

No patient returns were available for investigation.Field service was dispatched to the account and replaced the reagent probe and the peristaltic head tubing to resolve the issue.Customer complaint data was reviewed and no adverse trends or systemic issues were identified.The architect system operations manual was reviewed and was found to adequately address the issue.Based on the available information no product deficiency of the architect c16000 system was identified.

Event Description

The customer stated that an elevated cc magnesium result of > 3.90 mmol/l was generated.The sample was repeated and a result of 0.52 mmol/l was generated.The sample was also repeated on a second analyzer and a result of 0.52 mmol/l was generated.The elevated result was not reported.There was no report of impact to patient management.

• Brand Name: ARCHITECT C16000 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: 6946970
• MDR Text Key: 90312189
• Report Number: 1628664-2017-00377
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/12/2017

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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