MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+

Model Number 10379675

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the instrument and batteries to be returned for investigation.The customer has received a replacement instrument under warranty and they are operational.The cause of this event is unknown.

Event Description

The customer reported that when they inserted a new set of batteries into the instrument, it started smoking.There was no report of injury to user or property due to the event.

Manufacturer Narrative

Siemens evaluated the clinitek status+ returned by the customer.The instrument was returned in good condition with no damage to the exterior of the instrument.The instrument was returned without batteries or the brick portion of the power supply (cable only).The instrument has d16 damage on the main board.D16 failure caused the system to not operate.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 (device uses a common barrel connector) or using 3.5v rechargeable batteries (device specifies using common 1.5v aa batteries).The customer is operational with the new instrument.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9969687
• MDR Text Key: 188658930
• Report Number: 3002637618-2020-00018
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10379675
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR