MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE

Catalog Number 81600N

Device Problems High Test Results (2457); Calibration Problem (2890)

Patient Problem No Information (3190)

Event Date 03/10/2015

Event Type  Injury  

Event Description

The customer reported non-reproducible elevated troponin i (access accutni+3) results on the access 2 immunoassay system (serial number (b)(4)) for one patient.The initial sample recovered above the customer's normal reference range.The customer reanalyzed the same patient's sample on the same access 2 immunoassay system two additional times and obtained erratic results, both above the normal reference range.The results were not released from the laboratory, and there was a change in treatment as the patient was sent to the hospital to verify the results obtained.The customer reported that the patient's result from the hospital on the following day resulted within the normal reference range.Calibration, quality control (qc) and system check parameters met assay and system specifications before the event.After the event, the customer reported calibration and qc not meeting specifications.Beckman coulter (bec) customer technical specialist (cts) suggested that the customer perform a system check.The customer ran a system check routine which failed to meet specifications.Information on the patient sample collection and processing was not provided by the customer.

Manufacturer Narrative

The patients' demographics such as date of birth, gender, and weight were not supplied.Service was not dispatched for the event.As part of troubleshooting with the customer, beckman coulter technical specialist (cts) confirmed the presence of air bubbles in the main pipette line.The customer inspected the tubing between the fluidics tray and the instrument and confirmed that the tubing was kinked.Cts assisted the customer in straightening the tubing and performing a pipettor prime procedure.After this procedure, air bubbles are no longer present in the main pipettor line.A system check and a precision run using both the high and low level qc met specifications.Use error in the placement of the fluidics tray and the instrument caused a kink in the tubing which was the cause of the erratic results.

• Brand Name: ACCESS 2 IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 4642190
• MDR Text Key: 16175909
• Report Number: 2122870-2015-00188
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922823/A007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR