MAUDE Adverse Event Report: BECKMAN COULTER, INC. IMMAGE 800; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	IMMAGE 800 FINAL ASSY - PKGD
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Beckman coulter field application specialist (fas) assisted the customer with the immage analyzer.Fas advised customer to dilute the sample.The customer diluted the sample and obtained results considered correct.Fas did could not identify a failure mode.No parts were replaced.There is no evidence of a system malfunction.Section e1, initial reporter telephone number is (b)(6) the beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of a false low rheumatoid factor (rf) patient result on their immage 800 analyzer.The customer reported that there was a delay in patient treatment.No further information was provided.There was no report of harm to the patient.The customer provided data for one patient.

• Brand Name: IMMAGE 800
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 20242725
• Report Number: 2050012-2024-00080
• Device Sequence Number: 20655842
• Product Code: JJE
• UDI-Device Identifier: 15099590265403
• UDI-Public: (01)15099590265403(11)190711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962294
• 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
• Report Date (Section B): 09/17/2024

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: IMMAGE 800 FINAL ASSY - PKGD
• Device Catalogue Number: A15445
• 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: 08/29/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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 Age: 60 YR
• Patient Sex: Female