MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS + ANALYZER; CT STATUS + ANALYZER

Catalog Number 10379677

Device Problems Device Markings/Labelling Problem (2911); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

Customer reported incorrect patient id on instrument when barcode label was scanned.There was no report of injury due to this event.

Manufacturer Narrative

After going through other patient results, the customer reported the incorrect patient id due to operator error.Cause was due to the patient id barcode not being scanned properly by the operator.Instrument is working as intended.

Manufacturer Narrative

Initial mdr # 1217157-2014-00051 was filed with the fda on 04/07/14.

Manufacturer Narrative

Correction: cause was not due to the incorrect barcode being scanned, this issue is due to operator error.The error was incorrect selection of information on the instrument.

• Brand Name: CLINITEK STATUS + ANALYZER
• Type of Device: CT STATUS + ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIANOSTICS; manufacturing, ltd; northern rd; sudbury, suffolk uk CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater drive; norwood, MA 02062-CO10 ; UK 02062CO10 ; 7812693655
• MDR Report Key: 3731823
• MDR Text Key: 4308958
• Report Number: 1217157-2014-00051
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10379677
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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