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

Model Number AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

The customer reported the au680 clinical chemistry analyzer generated erroneously high patient results for ise (ion selective electrode) sodium (na), potassium (k) and chloride (cl).The patient samples were repeated on a different au680 and obtained results considered correct by the customer.There was no report of change to treatment, injury, or death associated to this event.The customer did not provide patient data or demographics.

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched to the customer site on multiple work orders.The fse evaluated the au680 clinical chemistry analyzer on work order (wo) (b)(4) and as troubleshooting measure the fse replaced the sodium (na) electrode and peralistic tubing.However, the high results still occured.The fse returned onsite on (b)(4) as troubleshooting measure primed system, and noted that not enough reagent was drained or being supplied to ise sample pot.The fse found a discolored tubing and malfunctioning ise buffer valve.The fse determined the failure mode was due to hardware malfunction.The fse replaced the ise (ion selective electrode) buffer valve, na electrode, and ise tubing to resolve the issue.Due to multiple interventions performed, a specific part cannot be identified as the sole contributor of this event.A failure of one or more of the replaced components or a combination thereof is the likely cause of this event.No patient demographic information (age, gender, weight, race or ethnicity) was provided.Initial reporter phone number is (b)(6).Beckman coulter internal identifier is (b)(4).

• 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; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 15537182
• MDR Text Key: 301109999
• Report Number: 9612296-2022-00312
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)180309
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K961274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE
• Device Catalogue Number: B96696
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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