MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 CUVETTE SEGMENT

Catalog Number 02P75-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

An abbott investigation has determined that the bottom of the cuvette segment may detach due to either excessive force applied during manual cleaning of cuvettes or cuvette wash tower crashes, or due to lack of sufficient glue during cuvette segment manufacturing (c4000 and c8000 only).A product correction letter will be issued to all current architect c4000 analyzer, architect c8000 system and architect c16000 system customers to inform them that the base of the architect cuvette segment may become detached under specific conditions causing the potential for falsely depressed clinical chemistry patient results to be generated.The letter provides additional guidance for the operators to inspect cuvette segments in situations where excessive force may have been applied including manual cleaning and/or cuvette washer movement errors.

Event Description

The customer observed frequent error code 1053 flagging (unable to calculate result, rate reaction linearity failure) for alkaline phosphatase patient results on the architect c4000 analyzer.Multiple troubleshooting steps were performed, including manually cleaning the c4000 cuvettes, to resolve the issue.No adverse impact to patient management was reported.

Manufacturer Narrative

The correction/removal reporting number was added to correction/removal number.The product correction letter was issued on (b)(6) 2017.

• Brand Name: ARCHITECT C4000 CUVETTE SEGMENT
• Type of Device: CUVETTE SEGMENT
• 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: 7071809
• MDR Text Key: 93829865
• Report Number: 1628664-2017-00460
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02P75-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1628664-12/11/17-003-C
• Patient Sequence Number: 1