MAUDE Adverse Event Report: BECKMAN COULTER IMMAGE 800 IMMUNOCHEMISTRY SYSTEM; NEPHELOMETER, FOR CLINICAL USE

Model Number	IMMAGE 800 FINAL ASSY - PKGD
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer questioned low rheumatoid factor (rf) patient result on their image 800 analyzer.The customer stated the inaccurate results resulted in delay in patient treatment for one (1) patient.The customer did not provide any information regarding change in patient treatment.There was no report of death associated with this event.The customer provided a example of rf result.
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the immage 800 immunochemistry system.The fse did not identify any system or hardware malfunction.The failure mode for this event is unknown.No parts were replaced.There is insufficient evidence to suggest that the system or reagent malfunctioned.The customer repeated the patient sample after dilution and obtained results considered correct by the customer.Per the rf supplemental product information insert it indicates that " if the patent's clinical condition does not correlate with the reported rf concentration, dilute the sample and repeat the analysis." the hospital did not provide any information regarding patient treatment.Section a4, and a5: information not provided by customer.Section e1 initial reporter phone number 18663522952.The beckman coulter internal identifier is case-2024-02582005-1.

• Brand Name: IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
• Common Device Name: NEPHELOMETER, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: angela vettel ; 250 s. kramer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 19802851
• Report Number: 2050012-2024-00055
• Device Sequence Number: 8379468
• Product Code: JQX
• 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): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IMMAGE 800 FINAL ASSY - PKGD
• Device Catalogue Number: A15445
• Device Lot Number: N/A
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/23/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Female