MAUDE Adverse Event Report: BECKMAN-COULTER UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A30260

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2015

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 total bhcg (5th is) reagent pack on the laboratory's unicel dxi 600 access immunoassay system instrument.In conclusion, although use error is the cause of this event, the system software malfunctioned as it did not detect a misloaded pack.(b)(4).All mdrs associated with this report: mdr2122870-2015-00889, mdr2122870-2015-00890.

Event Description

The customer loaded an incorrect beta human chorionic gonadotropin (access total bhcg (5th is)) reagent pack on the laboratory's unicel dxi 600 access 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) was troubleshooting another issue with the customer and had the customer unload the access total bhcg (5th is) reagent pack from each unicel dxi 600 access immunoassay system.When the customer went to reload the access total bhcg (5th is) reagent packs, they loaded each access total bhcg (5th is) reagent pack on the wrong unicel dxi 600 access immunoassay system.The unicel dxi 600 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.In this event, the customer had not received any related error messages or system flags at the time of the event that would have notified the customer that incorrect reagent packs were loaded on the wrong instrument.

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: UNICEL DXI 600 ACCESS 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: 5330640
• MDR Text Key: 34530716
• Report Number: 2122870-2015-00889
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023764
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A30260
• 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: 03/14/2011
• 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