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

Model Number	D-DIMER, R1 2 X 12.5 ML, R2 2 X 12.5 ML
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Beckman coulter complaint handling unit reviewed the event involving the au5800 chemistry analyzer.The customer stated that they mistakenly used the level 1 calibrator for both calibration set points, which resulted in a flat calibration curve.Consequently, false results were generated.The customer correctly used level 1 and level 2 calibrators to resolve the issue.No further issues have been reported.Patient information not provided by customer.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is case (b)(4).
Event or Problem Description
The customer reported the generation of false high d-dimer patient results on their au5800 chemistry analyzer.The customer reported six (6) patients were referred for a computer topography (ct) scan.The ct scans for all patients returned negative for deep-vein thrombosis (dvt) and pulmonary embolism (pe).Although no information has been received regarding the use of a contrast medium in the ct scans, it is highly likely that contrast medium was used due to the assessment of dvt and pe.No patients received any medications or any other procedures after the ct scans.The customer did not provide data or patient demographics.

• Brand Name: AU5800 CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 10196625
• Report Number: 9680746-2020-00003
• Device Sequence Number: 2560893
• Product Code: JJE
• UDI-Device Identifier: 15099590000332
• UDI-Public: (01)15099590000332(17)210201(11)191101(10)2201
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K070453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: D-DIMER, R1 2 X 12.5 ML, R2 2 X 12.5 ML
• Device Catalogue Number: OSR60135
• Device Lot Number: 2201
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/09/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other