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

Catalog Number 02P24-40

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated falsely elevated calcium on patient samples that repeated lower when processing on the architect c4000.Patient #2 generated architect calcium of 17.7 mg/dl but repeated 6.8 mg/dl.Patient #3 generated architect calcium of 20.5 mg/dl but repeated within the normal range.The account uses a normal calcium reference range of 8.5 to 10.5 mg/dl.No impact to patient management was reported.No specific patient information was provided.

Manufacturer Narrative

The product evaluation was performed by reviewing the complaint text, instrument service history, tracking and trending metrics, and the current labeling for the architect system operations manual.A review of the complaint text indicated troubleshooting was performed by laboratory staff, which included recalibration of the sample pipettor and replacement of a dirty and discolored cuvette dry tip.A cuvette wash was also performed and the calcium assay was recalibrated.The cuvette dry tip was considered to be the likely cause of the elevated calcium results.The trending data for the cuvette dry tip did not identify a product issue; furthermore, the erratic result rates were within expected limits for the architect c4000 system.A review of the product labeling concluded that the issue is sufficiently addressed.Taken together, no systemic issue or product deficiency was identified.

Manufacturer Narrative

A product correction letter was issued 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 also 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 found 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: 6711950
• MDR Text Key: 80066949
• Report Number: 1628664-2017-00283
• Device Sequence Number: 0
• Product Code: CJY
• 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: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

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: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 08/20/2018
• Supplement Dates FDA Received: 08/17/2017; 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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