MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. LABPRO COMPUTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 05/10/2014

Event Type  Death  

Event Description

The customer reported to siemens that the specimen ran using posbcombo panel type 20 and resulted on (b)(6) 2014 was identified as listeria monocytogenes and labpro (version 4.11) did not transmit the results to the lab info system (lis).The customer was concerned that there was a delay in treatment and delay in reporting to the cdc (results of listeria monocytogenes).Further confirmation with the customer indicates that the lab manager was not informed by the lab personnel of the specimen results until (b)(6) 2014 and therefore based on their procedure, it resulted in the delay in reporting to cdc which is a requirement by the (b)(6) department of health.On (b)(6) 2014, the customer reported to siemens that the pt passed away on (b)(6) 2014.Also noted on this date was possible mis-identification.Info about the pt treatment and/or cause of death was not provided.The specimen was sent to the state lab and to quest for id confirmation.The customer informed siemens of the quest results on (b)(6) 2014, indicating that the id should be on actinomyces species.After listeria was originally reported on (b)(6) 2014, the pt was placed on ampicillin and gentamicin.The nurse indicates there was no change in condition after being placed on this treatment.After further discussion with the listeria mis identification with the customer, the customer indicates that this is an identification that she never reported before but since (b)(6), she has reported 3 to the state.

Manufacturer Narrative

The device was not returned for eval.The configuration report sent by the customer and reviewed by siemens headquarter support center (hsc) revealed the customer's lab info system (lis) device is not setup for auto-transmission, therefore transmission of results would be manual.The lis is also not setup to any transmission filters.Based on the provided log files, there was no objective evidence of delay in transmission of the results from labpro.The labpro interface log of the specimen number provided by the customer shows that on (b)(6) 2014 this specimen was transmitted multiple times without error.Info about the pt treatment and/or cause of death was not provided.

• Brand Name: LABPRO COMPUTER
• Type of Device: LABPRO COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9143743031
• MDR Report Key: 3877186
• MDR Text Key: 4508294
• Report Number: 2919016-2014-00023
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 61