MAUDE Adverse Event Report: BECKMAN COULTER CRP LATEX REAGENT; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Model Number CRP LATEX, R1 4 X 50 ML, R2 4 X 50 ML

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

A beckman coulter customer technical support (cts) reviewed the customer's provided data and suspected possible sample interference due to the patient has monoclonal igm gammopathy.The customer was advised to send the patient¿s future samples to another laboratory to be tested on a different methodology for confirmation.No specific failure mode has been identified.No hardware, equipment, reagent or consumable malfunction was identified.The customer did not request for service.Beckman coulter internal identifier is (b)(4).Sample was from an (b)(6) years old male patient.Other patient demographic information was not provided.Customer phone number (b)(6).This is a corrected report for mdr report number: 9612296-2021-00046.Update information with the change in device, and device manufacturing site: product brand name, product code and model number.Manufacturing site, name and address.510k number for crp reagent pn osr6299.

Event Description

The customer in (b)(6) reported the au5800 clinical chemistry analyzer generated high c-reactive protein (crp) result drawn from one patient.The reported crp result was around 470 mg/l.On 21january 2021, the customer informed beckman coulter customer technical support (cts) that the patient was admitted to the hospital.It is unknown what medical intervention was provided.The patient¿s plasma sample was tested for crp on an unknown analyzer (unknown methodology) that yielded a lower result of 15 mg/l.Beckman coulter cts confirmed that the sample was from a patient who followed in the oncology service at the hospital.

• Brand Name: CRP LATEX REAGENT
• Type of Device: CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER IRELAND INC.; 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: 11520815
• MDR Text Key: 249133402
• Report Number: 9680746-2021-00022
• Device Sequence Number: 1
• Product Code: NQD
• UDI-Device Identifier: 15099590020392
• UDI-Public: (01)15099590020392(17)220201(11)200801(10)2687
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: CRP LATEX, R1 4 X 50 ML, R2 4 X 50 ML
• Device Catalogue Number: OSR6299
• Device Lot Number: 2687
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/09/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81