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

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Siemens is investigating this issue.

Event Description

The operator of a versacell sample management system reported that patient samples were found in the wrong locations on the system.The customer looked up patient sample (b)(6).Versacell indicated that sample was in position 488 b2, however, sample (b)(6) was located in that position.When sample (b)(6) was queried, versacell returned a different location of 469 a5.There are no reports of patient intervention or adverse health consequences due to the incorrect location of patient samples.

Manufacturer Narrative

The initial mdr 2247117-2016-00084 was filed on november 28th, 2016.Additional information (11/28/2016): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse verified robot alignments, bar code reader, and pick and place.The issue reported could not be duplicated.Upon follow up, the customer stated they have not had any additional errors.The cause of incorrect location of patient samples on the instrument is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: CLINICAL CHEMISTRY 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6130232
• MDR Text Key: 60995757
• Report Number: 2247117-2016-00084
• Device Sequence Number: 0
• Product Code: CGJ
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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
• Date Manufacturer Received: 11/28/2016
• 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