MAUDE Adverse Event Report: BECKMAN COULTER IMMAGE 800 CLINICAL CHEMISTRY ANALYZER; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The beckman field applications specialist evaluated the analyzer and found no evidence of a system or reagent malfunction.The customer repeated the sample with and without dilution, both results were comparable.The analyzer resumed to normal operation.Section a2, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(6).
Event or Problem Description
The customer reported obtaining low patient result for rheumatoid factor (rf) on their immage 800 clinical chemistry analyzer.The customer diluted (1:36) the sample and repeated with result was higher.The customer also repeated the sample without dilution on another analyzer and result was also higher.Due to results discrepancy, the customer indicated there was a delay in patient treatment.The customer did not provide further details regarding this patient.The customer reported this adverse event to national medical products administration (nmpa) for the reported delay in patient treatment.There was no report of death associated with this event.The customer did not provide patient demographics.The customer provided the results for this patient.

• Brand Name: IMMAGE 800 CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 20208769
• Report Number: 2050012-2024-00078
• Device Sequence Number: 18074207
• 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): 09/12/2024

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
• 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: 08/27/2024
• Initial Report FDA Received Date: 09/12/2024
• 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: 75 YR
• Patient Sex: Male