MAUDE Adverse Event Report: BECKMAN COULTER GLUCOSE

Catalog Number	OSR6221
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GLUCOSE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• MDR Report Key: 7523165
• Report Number: 9680745-2018-00003
• Device Sequence Number: 11089069
• Product Code: CFR
• UDI-Device Identifier: 15099590020101
• UDI-Public: (01)15099590020101(17)190901(11)170901(10)2602
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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 Catalogue Number: OSR6221
• Device Lot Number: 2602
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1