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

Model Number 10379675

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The customer has agreed to return the instrument to siemens for investigation.The customer stated that both batteries and the original power supply are connected to the instrument, however they are unsure if they were both in use at the time of the event.The instrument has not yet been received by siemens.The cause of this event is unknown.

Event Description

The customer reported that they noticed a burning smell and saw smoke coming from their status+ instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens evaluated the clinitek status returned by the customer.The instrument was returned in fair condition.The instrument was returned with the original power supply, however no batteries were included.The instrument has a d16 damage on the main board.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 instrument has been replaced and 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: 10303431
• MDR Text Key: 199868894
• Report Number: 3002637618-2020-00037
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1