MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens has replaced the instrument and has requested the original instrument to be returned for investigation.The cause of the event is unknown.

Event Description

The customer reported that the clinitek status+ started smoking from the paper slot when printing a result.There were no flames.The instrument has been unplugged and has not been used.There was no injury reported due to this event.

Manufacturer Narrative

Siemens has completed the investigation into the smoke coming from the clinitek status+.The conclusion is that the d16 was the source of the burning smell, but it is not a fire risk.D16 fails when incorrect power is connected to the device, either through plugging in the wrong power supply (status uses a common barrel connector) or using 3.5v rechargeable batteries (device specifies using common 1.5v aa batteries).The customer is operational with a new instrument.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8112533
• MDR Text Key: 129201342
• Report Number: 3002637618-2018-00131
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 10379675
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1