MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. CLINITEK ADVANTUS

Catalog Number 10636672

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

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.

Event Description

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.

Manufacturer Narrative

(b)(4).

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne,, MA 62080 ; PL 62080 ; 7812693655
• MDR Report Key: 6157805
• MDR Text Key: 61881920
• Report Number: 3002637618-2016-00165
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: Nurse
• Device Catalogue Number: 10636672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1