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

Catalog Number 02P75-01

Device Problems Low Test Results (2458); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2017

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 error code 4005, unable to read segment id bar code on reagent carousel 1 segment (x), on the architect c4000 analyzer serial number (b)(4).He noticed that one cuvette segment was not seated properly.After reseating, the error code persisted.Abbott field service was dispatched and manually cleaned all cuvettes and replaced one cuvette segment.There was no reported impact to patient results or patient management.

Manufacturer Narrative

The correction/removal reporting number was added.The product correction letter was issued on december 8, 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: 7073929
• MDR Text Key: 93699011
• Report Number: 1628664-2017-00487
• 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: Medical Technologist
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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