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

Catalog Number 10379675

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens customer service engineer (cse) reviewed cleaning technique of test table with customer.Customer stated that the insert is cleaned after every test with an alcohol swab and calibration bar is cleaned with gauze and tap water.Cse explained customer to use distilled water for proper cleaning of calibration strip.Customer indicated that they have been able to intermittently pass qc but qc has failed and due to qc lockout not being setup on instrument they proceeded to run patient tests without qc passing.Customer should not have run patient samples when qc failed.Cse explained customer that correct range for level 2 control according to insert is 100-300 for creatinine and would put their control in range.Customer stated that he would double check with his supervisor and let cse know after they confirm the control range.The event has occurred due to an operator error.

Event Description

Customer indicated that patient samples were run while automatic quality controls were out of range for microalbumin2 strips.Customer stated that qc was last run and passed on (b)(6) 2015.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 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: 5319262
• MDR Text Key: 34886770
• Report Number: 1217157-2015-00190
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1