MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER

Model Number SYNGO LAB DATA MANAGER

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.On 31-may-2018, the cse replaced the syngo lab data manager (sldm) instrument.The cause of the event is unknown.No further evaluation of this device is required.Mdr 2517506-2018-00390 was filed for the delay in patient testing on (b)(6) 2018.

Event Description

A customer reported that smoke was emitted from a syngo lab data manager (sldm) instrument.Upon inspection, the customer observed flames within the instrument; the customer reported that the flames and smoke were contained and dissipated within the instrument.The customer indicated that there was a delay of reporting patient result for 48 hours due to this issue.There was no impact to patients as the customer manually ran and released results to the laboratory information system during this timeframe.There are no known reports of patient intervention or adverse health consequences due to the delay in reporting of results.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2018-00389 on 22-jun-2018.Additional information (28-june-2018): the customer further reported that they manually entered patient results to the laboratory information system for 6 days.Mdr 2517506-2018-00390_s1 was filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr on 22-jun-2018 and the initial supplemental mdr s1 on 23-jul-2018.Additional information (30-jul-2018): siemens further investigated the event and observed dust buildup on the power cable to the hard drive of the instrument, which potentially caused the power cable to melt.The instrument potentially emitted flames and smoke due to the melting power cable.The replaced syngo lab data manager (sldm) instrument is receiving orders and sending results to the laboratory information system.The conclusion code of section h6 was updated to reflect the additional information.No further evaluation of this device is required.Mdr 2517506-2018-00390_s2 was filed for this issue.

• Brand Name: SYNGO LAB DATA MANAGER
• Type of Device: SYNGO LAB DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7630750
• MDR Text Key: 112565959
• Report Number: 2517506-2018-00389
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

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: SYNGO LAB DATA MANAGER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 07/30/2018
• Supplement Dates FDA Received: 07/23/2018; 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1