MAUDE Adverse Event Report: BECKMAN COULTER DYNAMIC INLET, POWER EXPRESS; RADIOASSAY, VITAMIN B12

Model Number DYNAMIC INLET, POWER EXPRESS

Device Problem Erratic Results (4059)

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

The customer reported that a stat rack in bay 7 of dynamic inlet was misidentified as centrifuge bypass rack in power express system.As a result, three sample tubes were routed on the line and were sorted to the connected instruments which generated results, validated, and hosted to lis (laboratory information system).The uncentrifuged sample routed to dxc 800 instrument.The customer reported receiving erroneous patient results for multiple analytes for the cmp (comprehensive metabolic profile).The sample was whole blood and an erroneous results were generated for na (sodium), k (potassium), cl (chloride), co2 (carbon dioxide), bun (blood urea nitrogen), glu (glucose), crea (creatinine), calc (calcium), tp (total protein), alb (albumin), tbil (total bilirubin), trig (triglycerides), cholesterol alp (alkaline phosphatase), alt (alanine aminotransferase) and ast (aspartate aminotransferase).The erroneous results were reported outside of the lab.There was no change in patient treatment in association with this event.

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched and evaluated the device.The field service engineer (fse) replaced the rack switches to resolve the issue.(b)(4).No patient demographic information (age, gender, weight, race or ethnicity) was provided.

• Brand Name: DYNAMIC INLET, POWER EXPRESS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12411371
• MDR Text Key: 280606298
• Report Number: 2050012-2021-00057
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590672324
• UDI-Public: (01)15099590672324(11)160501
• Combination Product (y/n): N
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNAMIC INLET, POWER EXPRESS
• Device Catalogue Number: PK201605005
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1