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

Catalog Number 10379680

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

The customer reported their status+ instrument began smoking and produced a strange smell when powering on.The customer immediately turned the instrument off.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has requested the customer return the isntrument and power supply for further investigation.The customer has declined and sent photos for evaluation instead.Investigation is underway.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation.The d16 on the main board was source of the burnt 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).Additionally, this can be caused by any natural event causing a power surge.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 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: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15470659
• MDR Text Key: 305979252
• Report Number: 3002637618-2022-00060
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1