MAUDE Adverse Event Report: BECKMAN COULTER IRELAND AU5800 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	CREATININE, R1 4 X 51 ML, R2 4 X 51 ML
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter complaint handling unit performed review of the reaction monitors.There is no evidence of sample dispensing, reagent dispensing/mixing or photometric issue.The reaction profiles are as expected.There was no report of sample integrity.Only one (1) patient sample was affected by this event.There is evidence of a reagent malfunction as discrepant results were obtained with creatinine osr6178 application.This is a patient specific issue.The batch history records were reviewed for osr6178 lot 2599.The batch passed all quality control (qc) release specifications.A complaint search was performed.No other complaint has been logged for osr6178 lot 2599; therefore, this issue is not creatinine lot specific issue.The discrepancy in results is most likely cause by an unknown interference.The patient medication history was requested which indicated the patient was treated with furosemide (20 mg per day), bisoprolol, lercanidipine, alprazolam and previscan.Per young, d.S., effects of drugs on clinical laboratory tests, aacc press, 5th edition 2000: bisoprolol, lercanidipine, alprazolam and previscan and low doses of furosemide (<30 mg/dl) are not reported to have any analytical effect on the creatinine osr6178 (colorometric method).Based on the information provided, the interferent could not be conclusively identified.Information not provided by customer.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 creatinine result for one (1) patient sample on the au5800 clinical chemistry analyzer.The erroneous patient result was reported outside the lab.Due to the false low creatinine patient result, the patient was scanned and received an intravenous injection of iodine contrast agent.There was no adverse effect to the patient.

• Brand Name: AU5800 CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o`callaghan`s mills, co clare ; EI
• Manufacturer (Section G): BECKMAN COULTER IRELAND; lismeehan; o`callaghan`s mills, co clare ; EI
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 9613448
• Report Number: 9680746-2020-00001
• Device Sequence Number: 2216204
• Product Code: JJE
• UDI-Device Identifier: 15099590010737
• UDI-Public: (01)15099590010737(17)210701(11)190701(10)2599
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924692
• 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): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CREATININE, R1 4 X 51 ML, R2 4 X 51 ML
• Device Lot Number: 2599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 01/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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 Sex: Unknown