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 Consequences Or Impact To Patient (2199)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The customer observed that a puddle had formed under the instrument and requested service to troubleshoot the issue.The abbott field service representative (fsr) performed significant troubleshooting and stated that the leaking bellows set was the likely cause for the discrepant result.There were no additional discrepant results (or leaking) reported on (b)(4) after the bellows set was replaced.A review of historical data revealed no systemic issue or adverse trends associated with the bellows set, part number 2-89055-02, or the issue described in this complaint (erratic / discrepant results).A review of labeling concluded that the issue is sufficiently addressed.The issue was resolved by the field service representative through standard troubleshooting procedures.Based on the available information, a deficiency of the part(s) was not identified.

Event Description

The customer stated that a falsely elevated architect magnesium result of 3.18 mmol/l was generated for a patient sample that retested at 0.88 and 0.89 mmol/l.The initial elevated result was not reported out of the laboratory.No adverse impact to patient management was reported.

• 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: 5563253
• MDR Text Key: 42622145
• Report Number: 1628664-2016-00088
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/08/2016

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 39 YR