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

Catalog Number 81600N

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

No patients were involved in this event.Beckman coulter (bec) customer technical support (cts) determined that the customer had misloaded the access prolactin reagent pack in place of an access free t4 reagent pack on the laboratory's access 2 immunoassay system instrument.In conclusion, although use error is the cause of this event, the system software malfunctioned as it did not detect that the reagent pack had differing well volumes from the access free t4 reagent pack.

Event Description

The customer reported obtaining a reagent carousel motion error while unloading reagent packs on the laboratory's access 2 immunoassay system serial number (b)(4).The customer stated that no patient results were generated in association with this event.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 the on-board reagent packs' placement in the reagent carousel as compared to the user interface (ui) inventory list.It was subsequently discovered that an access prolactin reagent pack was in place of an access free t4 reagent pack.On the reagent carousel.The ui inventory listed the access free t4 reagent pack in this position and the access prolactin pack had been misloaded and placed in the wrong position.Forty-two tests remained in the ui inventory list for the access free t4 pack indicating that eight (8) tests had been used from the access prolactin pack instead.The access 2 immunoassay system serial number (b)(4) had, previous to this event, been updated with system software that alerts the customer to and detects reagent pack misloading due to the fact that reagent pack volumes would not match.In this event, the customer stated that they had not received any related error messages or system flags at the time of the event that would have notified the customer that reagent packs were loaded in the incorrect positions.

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 misload 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: 5244677
• MDR Text Key: 31969139
• Report Number: 2122870-2015-00783
• Device Sequence Number: 1
• Product Code: JJE
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• 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: 07/23/2015
• 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