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

Catalog Number 10332185

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Customer called back and stated that they figured out what happened.Customer indicated that there were 2 different samples on the same patient and both samples run using the same patient id and 1 sample had ph of 6.5 and negative blood and the other sample had ph of 7.0 and trace blood that's why the results in lis were 7.0 ph and trace blood because there were 2 different samples on same patient run using same patient number.Samples tested on different instruments and different locations and results from the second location went to lis.Customer confirmed that they are all set and there is no problem with instrument.Instrument is performing as intended.

Event Description

Customer reported that when they ran sample on instrument, using multistix 10sg strips, blood result printed out as negative and ph printed out as 6.5 whereas results in the lis were trace and 7.0 for blood and ph respectively.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS
• Type of Device: CT STATUS
• 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 ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6113759
• MDR Text Key: 60857388
• Report Number: 3002637618-2016-00156
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1