MAUDE Adverse Event Report: BECKMAN COULTER DXA 5000; RADIOASSAY, VITAMIN B12

Model Number ASSY, MAIN, PRIMARY, DRIVE, DUAL - TRAN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

A customer technical support (cts) was dedicated to troubleshoot the issue with the customer.The cts confirmed that the issue was due to non centrifuged sample.The customer spun the sample in an external centrifuge and reprocessed the sample to resolve.(b)(4).No patient demographic information (age, gender, weight, race or ethnicity) was provided.(b)(6).

Event Description

The customer reported a non centrifuged sample by the dxa 5000 system caused an erroneous patient result with multiple chemistries to be generated on the au5800 clinical chemistry analyzer.There was no change in patient treatment in association with this event.

• Brand Name: DXA 5000
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; munich 81377 ; GM 81377
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11263379
• MDR Text Key: 258586441
• Report Number: 3006655511-2021-00001
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590719654
• UDI-Public: (01)15099590719654(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K190298
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSY, MAIN, PRIMARY, DRIVE, DUAL - TRAN
• Device Catalogue Number: B50516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2983-2020
• Patient Sequence Number: 1