MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that to confirm correct results, they measured twice by manual microscopy and the results were both >10 rbcs (per high power field) which was reported.The multistix 10 sg strip is discarded after use so no investigation is possible.The customer stated that the instrument is operational.

Event Description

The customer reported different blood results between the strip measurement and the microscopic reading.There was no report of injury due to this event.

Manufacturer Narrative

Contact office - manufacturing site, changed name and address to: (b)(4).

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• 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: 6362614
• MDR Text Key: 68760979
• Report Number: 3002637618-2017-00029
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• 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: Health Professional
• Device Catalogue Number: 10484765
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/27/2017
• 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