MAUDE Adverse Event Report: BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number B12183

Device Problem Low Test Results (2458)

Patient Problem Injury (2348)

Event Date 11/20/2016

Event Type  Injury  

Manufacturer Narrative

A beckman coulter field service engineer (fse) found severe buildup on the inside of the ise electrode block.The fse replaced the ise electrode block and verified instrument operation.The primary failure mode is unknown; appears to be an isolated event.The redraw and repeat result of the original sample considered correct by the customer were obtained prior to the replacement of the ise electrode block.Patient demographics (weight, date of birth, gender, age) were not provided by the customer.

Event Description

The customer reported obtaining a false low potassium (k) result for one (1) patient, involving the au480 clinical chemistry analyzer (model au481-10e).The false low k result was reported outside the laboratory.The patient, who was in the emergency room for an unknown condition received two 25 meq oral potassium bicarbonate (k-effervescent) tablets as a result of the low potassium result.The patient was redrawn after treatment and the sample result was within the laboratory's established reference range (3.5-5.5 mmol/l).In addition, the customer repeated the original sample that had generated the low k result and obtained a result also within reference range.The patient was not admitted into the hospital and was discharged from the emergency room.

• Brand Name: AU480 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 s. kraemer blvd; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 6181458
• MDR Text Key: 62595653
• Report Number: 9612296-2016-00120
• Device Sequence Number: 0
• Product Code: CEM
• Reporter Country Code: US
• PMA/PMN Number: K981743
• 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
• Report Date: 11/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B12183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2016
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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
• Patient Outcome(s): Other