FDA Adverse Event Malfunction Summary report: N

DATALINK2000

MDR report key: 1032235 · Received April 21, 2008

Report

Report Number: 2050012-2008-00016
Event Type: Malfunction
Date Received: April 21, 2008
Date of Event: April 1, 2008
Report Date: April 21, 2008
Manufacturer: BECKMAN COULTER, INC.
Product Code: JJE
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: SINCE PT B'S SAMPLE ID WAS ASSOCIATED WITH THE CORRECT RESULT, THE RESULT WAS POSTED TO THE CORRECT DEMOGRAPHICS AT THE LIS. THE EVENT DATA FILES WERE COLLECTED AND FORWARDED TO THE SOFTWARE VENDOR FOR INVESTIGATION: THE DATA SHOWED AN ERROR ASSOCIATED WITH PT B, AND APPEARS THAT THE SYSTEM DEFAULTED TO THE MR # OF PT A WHICH IMMEDIATELY PRECEDED PT B IN THE SEQUENCES OF DOWNLOADS. PER SOFTWARE VENDOR, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED FROM THE AVAILABLE DATA. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

Description of Event or Problem · 1

A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT AN INCORRECT MEDICAL RECORD # (MR#) WAS GENERATED BY THE DATALINK2000 DATA MANGER (DL2000) FOR A SINGLE PT SAMPLE. PT A: SAMPLES WERE TESTED FOR T4. PT B: TWO SAMPLES WERE TESTED FOR TESTOSTERONE. ON THE INSTRUMENT PRINTOUT FOR PT B, THE DL2000 GENERATED CORRECT TESTOSTERONE RESULT AND THE CORRECT SAMPLE I.D., BUT WRONG MR#: THE INSTRUMENT PRINTOUT FOR PT B HAD NO NAME, AND THE MR # OF PT A. TREATMENT WAS NOT INITIATED OR WITHHELD AS THE CORRECT RESULTS WERE POSTED TO THE CORRECT PT DEMOGRAPHICS AT THE LAB INFO SYSTEM (LIS).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DATALINK2000	DATA MANAGEMENT SYSTEM	JJE	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA