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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated magnesium patient results generated using the architect c4000 analyzer.The following results were provided.The customer uses magnesium normal range 1.6 to 2.6 mg/dl.Patient 1, initial 8.6, repeat 1.9; patient 2, initial 9.0 repeat 1.9, 2.0.No impact to patient management was reported.

Manufacturer Narrative

An abbott field service representative (fsr) was dispatched to the account.The fsr replaced both the valve, poppet set (part 09d36-02) and bellows, bellows only (part 2-89054-02) during troubleshooting.Replacement of the valve, poppet set (part 09d36-02) resolved the customer issue and was designated by the fsr as the likely cause.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and a review of instrument service.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation, the analyzer performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product deficiency was identified.Conclusion code in evaluation codes was corrected.

• 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: 5921256
• MDR Text Key: 53708411
• Report Number: 1628664-2016-00224
• Device Sequence Number: 0
• Product Code: JGJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2017

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: 08/09/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/26/2016; 04/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: CLINICAL CHEMISTRY MAGNESIUM; LIST NUMBER 07D70-21; LOT NUMBER 26102UN16