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

Catalog Number 81600N

Device Problem Low Readings (2460)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2015

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter (bec) customer technical support (cts) determined that the customer had misloaded the access accutni+3 reagent pack onto the access 2 immunoassay system serial number 503083.The misloaded reagent pack led to under recovery of the patient results as no reaction was taking place.In conclusion, although use error is the cause of this event, the system software malfunctioned as it did not detect that the reagent pack was not present in the proper location on the instrument.

Event Description

The customer reported obtaining no value, ind (indeterminate) flagged troponin i (access accutni+3) patient results on the laboratory's access 2 immunoassay (system serial number (b)(4)).The results obtained presented substrate level rlus (relative light units) which indicated that no reaction was taking place for this assay.The three ind flagged results were not released from the laboratory.There was no change to or impact to patient treatment in connection with this event.Beckman coulter (bec) customer technical support (cts) assisted the customer with verifying reagent pack placement on the access 2 immunoassay system by comparing the user interface (ui) software to the physical placement of the on-board reagent packs.It was subsequently discovered that the access accutni+3 reagent pack had not been correctly loaded in the proper carousel slot which led to the no value, ind flagged patient results.The access 2 immunoassay system serial number (b)(4) had, previous to this event, been updated with system software that detects reagent pack misloads and alerts the customer.In this event, the customer stated that they had not received any error messages or system flags.

Manufacturer Narrative

After further review by the bec (beckman coulter) chu (complaint handling unit), it was determined that there was no malfunction associated with this event.The system software was performing as designed at the time that the pack sharing was identified.Use error is still determined to be the cause of this event.

• Brand Name: ACCESS 2 IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), 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: 5192015
• MDR Text Key: 29977607
• Report Number: 2122870-2015-00734
• 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,Followup
• Report Date: 10/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2005
• 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