MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY ANALYZER; DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE

Catalog Number 81600N

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

System performance indicator data (qc, calibration, system checks) supplied by the customer are highly suggestive of a hardware malfunction.However, the beckman coulter fse dispatched to the customer site performed a preventive maintenance which involves the replacement of multiple parts that could have contributed to this event.No determination of the specific failure mechanism could be made.

Event Description

On (b)(6) 2016 the customer reported that erroneous high accutni+3 results had been generated for four patients on the laboratory's access2 immunoassay system serial number (b)(4).The issue was detected when the customer observed that accutni+3 values for quality control samples processed contemporaneously with the patient samples in question were unacceptable.The customer reassayed the patient samples on the laboratory's unicel dxi 600 access immunoassay system serial number (b)(4) and lower results within the assay's normal reference range were obtained.The customer indicated that the initial results were reported out of the laboratory and that corrected reports were issued.The customer indicated that no change to patient treatment had occurred as a consequence.The customer reported that the primary samples were collected in lithium heparin gel separator tubes.The customer reported the samples were centrifuged for five minutes at an unknown rpm (rotations per minute) at room temperature.The customer reported that samples were processed from the primary tubes.A beckman coulter fse (field service engineer) was dispatched to the customer site to evaluate the system.

• Brand Name: ACCESS 2 IMMUNOASSAY ANALYZER
• Type of Device: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE
• 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: 5522503
• MDR Text Key: 41035439
• Report Number: 2122870-2016-00158
• Device Sequence Number: 0
• Product Code: MMI
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2016

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: 81600N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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