MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM; GENERAL PURPOSE LABORATORY EQUIPMENT

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problem Failure to Back-Up (1047)

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

Event Date 05/31/2013

Event Type  malfunction  

Event Description

The customer reported that a cardiac troponin i (tniu) test for one patient was not processed because the versacell system did not save the test order for samples that were manually loaded on the connected analyzer (advia centaur xp system).There are no reports of adverse health consequences due to the versacell system not saving test orders for samples that were manually loaded.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the versacell sample management system and data, the cse determined that when the customer was frontloading a sample rack onto the advia centaur xp system, a 'no request' status was obtained and the sample rack was ejected from the analyzer.The cse determined that when the customer re-loaded the same sample rack on the advia centaur xp system, the laboratory information system (lis) order was received from the host.The cse verified that the versacell log files showed the sample in question was queried to the lis by the versacell and the test order for cardiac troponin i (tniu) was downloaded from the lis, however, it was not sent to the advia centaur xp by the versacell.The cause of the versacell not saving test orders for samples manually loaded at the connected analyzer is unknown.The cse instructed the customer that in cases where the operator must manually frontload a sample, the operator should verify that all test orders are downloaded as expected when removing an ejected rack from the advia centaur xp system.Siemens is currently investigating this issue.

Manufacturer Narrative

The initial mdr 2247117-2014-00024 was filed on april 29th, 2014.Additional information (06/02/2014): there is an indication to the operator that the sample is not processing in the versacell software in cases when the versacell does not transmit the test order to the connected analyzer for front loaded tubes.The customer should follow the recommendations previously provided for this situation.The open test orders will appear with a status of 'no sample' at the versacell lis screen.The operator may sort by sample status to determine any outstanding orders that may need to be processed.Mdr 2247117-2014-00024 the instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: GENERAL PURPOSE LABORATORY EQUIPMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: john nelson ; siemens healthcare diagnostics; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3777093
• MDR Text Key: 21726932
• Report Number: 2247117-2014-00024
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2013

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: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• 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: Reuse
• Patient Sequence Number: 1