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

Catalog Number 02P24-40

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was provided for one sample id (b)(6) with no age or gender provided.Patient identifier was not provided for six samples but age ranging of 54 to 88 years old with both male and female gender provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account generated falsely depressed magnesium on several samples processed on the architect c4000 analyzer.Seven patient samples generated magnesium ranging 0.8 to 1.0 mg/dl but repeated 1.7 to 2.3 mg/dl.The account uses a normal magnesium range of 1.6 to 2.6 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Abbott field service (fs) investigated the event on site and noticed the customer's quarterly maintenance was overdue.Fs trained the customer on the importance of performing maintenance on time.Fs addressed the issue by performing the quarterly maintenance and performing a pm that was due.No subsequent reports involving erratic or inconsistent results have been received.A review of architect c4000 tracking and trending information did not identify any related issues or trends and the c4000 erratic result rate is within acceptable limits with no trends identified in the 12 month review period.Additionally, no related nonconformity for the c4000 were identified.A review of the product labeling concluded that the issue is sufficiently addressed.A use error may have contributed to the issue as the customer's quarterly maintenance was overdue.No systemic issue or deficiency was identified for the architect c4000.

• 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: 7009828
• MDR Text Key: 92318571
• Report Number: 1628664-2017-00430
• 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
• Report Date: 12/01/2017

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: 10/16/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1