MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2550; RADIOASSAY, VITAMIN B12

Model Number AUTOMATE 2550

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2023

Event Type  Injury  

Event Description

The customer reported that the sorting drive of their automate 2550 is aliquoting the wrong tube and storing the correct tube which resulted in the release of false troponin patient results.The customer reported that there was a change in patient treatment; however, no further information was provided.

Manufacturer Narrative

The customer did not provide information relating to the change in patient treatment.Beckman coulter field service engineer (fse) evaluated the automate 2550.The log files from the instrument were reviewed.The fse and application support manager determined that the files indicate that the customer may have had two tubes from two different patients.The log files did not indicate an issue with the instrument.There is no evidence of a instrument malfunction.The customer was satisfied with the support and no further issues were reported.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is case (b)(4).

• Brand Name: AUTOMATE 2550
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen bavaria 81379 ; GM 81379
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer Contact: alexander schwiersch ; sauerbruchstr. 50; münchen 81377 ; GG 81377
• MDR Report Key: 16569801
• MDR Text Key: 311559175
• Report Number: 3006655511-2023-00006
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590364083
• UDI-Public: (01)15099590364083(11)120702
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AUTOMATE 2550
• Device Catalogue Number: ODL25255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/18/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2012
• 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
• Patient Outcome(s): Other