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

Model Number 10379675

Device Problem Smoking (1585)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the instrument be returned for investigation.There was no injury reported as a result of this event nor was there any property damaged.The customer immediately unplugged the instrument when the smoke was seen.The customer is operational with a new instrument.The cause of this event is unknown.

Event Description

Customer reported visible smoke was observed upon plugging their clinitek status+ analyzer into the power source.The customer immediately unplugged the instrument and there were no further issues there is no report of injury due to this event.

• 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, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 16632165
• MDR Text Key: 312345880
• Report Number: 3002637618-2023-00007
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2023

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 Model Number: 10379675
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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