MAUDE Adverse Event Report: BECKMAN COULTER MISHIMA K.K. AU5800 CLINICAL CHEMISTRY ANALYSER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800

Device Problems High Test Results (2457); Delivery System Failure (2905)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter (bec) field service engineer (fse) was dispatched and evaluated the instrument.The fse identified a worn pin which is part of the r1 syringe drive mechanism.The motor that generates movement for the syringe has this pin (toothed gear).The fse replaced the complete syringe driver mechanism and no further issues were reported.

Event Description

On the (b)(6) 2016 the customer reported an error message and they identified an issue with the r1 (reagent) outer dispenser.This has a potential to cause erroneous results.It was reported that the results from the customer's au5800 analyzer were generally recovering (b)(4) higher when compared to repeat results generated on the second au5800 instrument in the lab.No specific erroneous results were provided.No change to patient treatment was reported.Also customer reported that false high total bilirubin and alt results that were reported out of the laboratory were amended.

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYSER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino,; nagaizumi-cho sunto-gun; schizuoka,, mishima JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: david davis ; 250 s, kraemer blvd.; m/s e1 .se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5735239
• MDR Text Key: 47716284
• Report Number: 9612296-2016-00083
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K112412
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800
• Device Catalogue Number: B23279
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1