MAUDE Adverse Event Report: BECKMAN COULTER GLUCOSE

Catalog Number OSR6221

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation indicates the reagent malfunctioned at the time of the event.Upon recalibration of the reagent in question, the quality control was restored.Patient sample were redrawn and the samples were repeated on two different au instruments with acceptable results.However, the same reagent of a different lot number was also in-use on the instrument.The repeat data provided did not indicate which reagent lot was used during the repeat testing.There were no reports of instrument issues.The customer indicated that the glucose issue has not reoccurred.Patient demographics were not provided.(b)(4).

Event Description

The customer reported having issues with glucose (glu) on their au5800 chemistry analyzer.The customer estimated 500 glu patient results were high but only two patient results were provided.The patient samples were redrawn and repeated on the same au and another au instrument and both results were lower.Original high results were reported out of the laboratory but instead of correcting the results, the customer attached a note to the results.The customer confirmed patient treatment was not impacted.Quality control (qc) was within their established range before the event; however, qc was out of range after the event.

• Brand Name: GLUCOSE
• Type of Device: GLUCOSE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER IRELAND; lismeehan; o'callaghan mills,, co. clare ; EI
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 7523165
• MDR Text Key: 108907721
• Report Number: 9680745-2018-00003
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 15099590020101
• UDI-Public: (01)15099590020101(17)190901(11)170901(10)2602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OSR6221
• Device Lot Number: 2602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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