MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

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.

Event Description

The customer reports falsely elevated architect clin chem phosphorus assay results being generated on an architect c16000 analyzer.A patient sample generated an initial result of 10.1 mg/dl (customer upper normal limit is 4.7 mg/dl).The sample retested at 3.9 mg/dl.Controls were within specification earlier in the day.The customer discovered two bent cuvette wash nozzles and a bent r1a probe on the instrument.The customer straightened the wash nozzles and replaced the r1a probe, but failed the r1a calibration due to lls failures.A service call was initiated.No suspect results were reported from the lab.There is no impact to patient management reported.

Manufacturer Narrative

An abbott field service representative (fsr) visited the customer site to trouble the customer issue on the architect c16000 analyzer.The fse adjusted the sensor, trigger, reaction carousel and nozzle pairs 2-3 (wash solution).Subsequent instrument operations and test results were acceptable.A review of complaint tracking and trending metrics was performed and identified no adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation.No returns were made available from the customer site.The architect system operation manual and the architect c16000 system and support manual contain information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT C16000 SYSTEM
• 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: 6819880
• MDR Text Key: 83683822
• Report Number: 1628664-2017-00322
• Device Sequence Number: 0
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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: CLIN CHEM PHOSPHORUS LN: (B)(4); LOT: 03268UN16