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

Model Number AU681-10DE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse replaced the r1 inner wash valve on the customers au680 analyzer.A malfunctioning r1 inner wash valve may lead to cuvette contamination and thus erroneous results as reported.Replacement of this part resolved the issue.The patient demographics were not provided by the customer.Beckman coulter internal reference number for this event is (b)(6).The related mdr's for this event documenting the other patients involved are: 9612296-2017-00044, 9612296-2017-00045.

Event Description

A customer reported the generation of false high glucose results on their au680 analyser.The erroneous patient results were released outside the laboratory.There was no report in change of patient treatment in connection with this event.The customer stated that ten (10) erroneous patient results recovered high for glucose.However on further communication with the customer it was clarified that five (5) patient samples recovered high for glucose with seven (7) erroneous results generated over three (3) different days.The customer stated that quality control (qc) was analyzed prior to and after the event and all were reported as being within specification.

• Brand Name: BECKMAN COULTER 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
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho; sunto-gun, shizuoka, 411-0 931; JA 411-0931
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821
• MDR Report Key: 6824361
• MDR Text Key: 83846510
• Report Number: 9612296-2017-00043
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K961274
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU681-10DE
• Device Catalogue Number: B96695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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