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

Model Number 6L45-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that an architect total bilirubin result of 17.2 mg/dl was reported for a newborn patient on (b)(6) 2017.Repeat testing (per reflex rule set up by the customer) was 7.4 mg/dl.The laboratory technician released the result of 17.2 mg/dl without checking for the reflex result.The baby was sent to the nicu where retesting for total bilirubin was 7.6 mg/dl.The customer is not aware of any treatment given to the baby.The repeat testing in nicu prompted the lookback at the architect results where the reflex result was discovered.No known unnecessary treatment was given and no injury was reported.

Manufacturer Narrative

An abbott field service representative (fsr) replaced the board, pm, c16000 and c4000 (part number 7-900040-02) as the pressure monitoring was not performing sample integrity checks.This part was considered the likely cause of the result issue.Review of the architect c401619 service history did not identify contributing factors on or around the date of the complaint.There were no subsequent contacts from the customer regarding discrepant results since the fsr visit.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency of the board, pm, c16000 and c4000 was identified.

Manufacturer Narrative

A product correction letter was issued on 17jul2018 to all architect clinical chemistry customers notifying them to adhere to the labeling instructions listed in the architect operations manual, section 10, to resolve error codes 3580 to 3585 or 5381 before transitioning the architect to the running status.The product correction letter provides guidance on how the customer can ensure the pressure monitoring system is functioning, and recommends following the architect systems operations manual and the assay-specific documentation to ensure all samples and reagents meet described requirements before being placed on the architect.The investigation into this event identified that when the pressure monitor board communication on the architect clinical chemistry analyzer is not successfully established during initial instrument boot up, and the following error codes 3580 to 3585 or 5381 are not resolved by the user prior to transitioning the architect to the running status, there is the potential to generate incorrect results as the pressure monitoring system is inactive.The architect system software will be updated in a future version to prevent the architect analyzer from transitioning to the running status when the pressure monitoring system is in an error state.

• 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: 6764215
• MDR Text Key: 81813757
• Report Number: 1628664-2017-00301
• Device Sequence Number: 0
• Product Code: MQM
• 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,Followup
• Report Date: 07/31/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6L45-21
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 08/21/2017; 07/02/2018
• Supplement Dates FDA Received: 08/24/2017; 07/31/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1628664-07/17/18-001-C
• Patient Sequence Number: 1