MAUDE Adverse Event Report: BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU681-02E

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The customer replaced the potassium electrode which resolved the issue.A precision run performed after replacement of the potassium electrode showed results within specification.The customer did not provide patient data and patient demographics.

Event Description

The customer reported obtaining false low potassium (k) results for an unknown number of patient samples, involving the au680 clinical chemistry analyzer.The false low potassium results were not reported outside the laboratory.The customer stated the initial sample results were flagged "critical low" and repeat sample results recovered within the normal reference range.There was no effect to patient treatment in connection to the event.Quality control was within the laboratory's established ranges on the day of the event.

• Brand Name: AU680 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K; 454-32 higashino; nagaizumi-cho sunto-gun, ; JA
• Manufacturer Contact: david davis ; 250 south kraemer blvd; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 6805997
• MDR Text Key: 83310997
• Report Number: 9612296-2017-00040
• Device Sequence Number: 0
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961274
• 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,Followup,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU681-02E
• Device Catalogue Number: N3663000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 08/03/2017; 08/03/2017
• Supplement Dates FDA Received: 07/30/2018; 09/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• 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