inforMED
MalfunctionJIL

CLINITEK ADVANTUS

Received Dec 9, 2016 · Event occurred Nov 11, 2016

Report 3002637618-2016-00165 · MDR key 6157805

Device

Generic name

Clinitek Advantus

Catalog number

10636672

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE CUSTOMER CONFIRMED THAT THE OPERATOR NOTICED THE DISCREPANCY IN A NUMBER OF RESULTS OF 6 PATIENTS THAT WENT ACROSS THE INTERFACE AND IMMEDIATELY ISSUED CORRECTED REPORTS AND STATED THAT NO PATIENT HARM OCCURRED DUE TO THIS ISSUE. THE CUSTOMER REPORTED THAT A REPLACEMENT BARCODE READER WAS RECEIVED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE BARCODE READER ON THEIR SYSTEM MISREAD THE PATIENT BARCODE LABEL RESULTING IN WRONG RESULTS BEING SENT ACROSS LIS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

(B)(4).