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

Model Number	AUTOMATE 2550
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006655511-2023-00006
• Device Sequence Number: 11949046
• Product Code: CDD
• UDI-Device Identifier: 15099590364083
• UDI-Public: (01)15099590364083(11)120702
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AUTOMATE 2550
• Device Catalogue Number: ODL25255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown