MAUDE Adverse Event Report: BECKMAN COULTER ACCESS IL-6 REAGENT; IMMUNOASSAY METHOD, INTERLEUKIN

Catalog Number A16369

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The full identifier is (b)(4).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access il-6 assay was not returned for evaluation.There were no reports of system issues at the time of the event.No other assay issues were reported.No hardware errors or flags were reported in conjunction with the event.System performance indicators of calibration and quality were not provided for review.The customer stated the lis reported the result at >1500 pg/ml and questioned this difference in reported results.The access il-6 assay reportable range is 0.5-1500 pg/ml.The s5 calibrator value is at 1634 pg/ml, the patient result is above this value and the high result is not questioned even if the customer was advised to dilute the sample by the local support to obtain an appropriate value.In conclusion, the cause of this event is use error.The reported issue is due to a use error in setting up the customer's lis.There is no malfunction of the il-6 assay.The lis is not a beckman coulter product.

Event Description

On (b)(6) 2021, the customer reported questioned il-6 (access il-6 assay, part number a16369, lot number 922941) patient results were observed in the customer's laboratory information system (lis) for one patient.The result of >1634 pg/ml (flagged as over range) which was generated on the customer's access 2 analyzer (access 2 immunoassay analyzer (part number 81600n and serial number (b)(4))) did not match the lis result of >1500 pg/ml.No affect to patients or end-users has been reported in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as calibration and quality control were not provided for review.No issues with sample integrity were reported by the customer.Sample handling information including sample type, collection, handling and processing information such as storage and other sample related information was not provided by the customer.

• Brand Name: ACCESS IL-6 REAGENT
• Type of Device: IMMUNOASSAY METHOD, INTERLEUKIN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12240827
• MDR Text Key: 265880485
• Report Number: 2122870-2021-00113
• Device Sequence Number: 1
• Product Code: QLC
• UDI-Device Identifier: 15099590201852
• UDI-Public: (01)15099590201852(17)220531(11)201207(10)922941
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: A16369
• Device Lot Number: 922941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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