MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSIONVISTA® SYSTEM; DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE,

Catalog Number K1021 SMN 10445159

Device Problem High Test Results (2457)

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

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has determined that dimension vista® blood urea nitrogen (bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba, 15320bb, and 15341ac may exhibit inaccurate patient and/or quality control results.Only specific reagent cartridge wells are affected.If calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50%.If calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64%.Siemens issued an urgent medical device correction dated february 2016, communication vc-16.01.B.Us to all u.S accounts or an urgent field safety notice vc-16-01.B.Ous, to all outside u.S.Accounts who had been shipped the impacted lots.Customers were directed to discard certain flexes with a specific lot number/cavity number combination.Siemens healthcare diagnostics confirmed additional complaints and has added additional blood urea nitrogen (bun k1021) lots 16004ab, 16034aa, 16033ac, 16048aa, 16055aa, 16055ab,16062aa, 16062ab as well as all future vista bun lots until further notice to the field action.An updated information communication umdc vc-16-01a.B.Us and ufsn vc-16-01a.B.Ous has been mailed in june 2016 to all accounts who have been shipped these lots.The communication advised customers to follow the additional instructions under the section "actions to be taken by the customer" to manage their bun testing.

Event Description

Discrepant bun patient results were obtained on the dimension vista(r) instrument.Patient results were reported to physicians.The samples were repeated on an alternate dimension vista and revised results were obtained.Corrected results were reported.There is no indication that patient treatment was altered or prescribed on the basis of discrepant bun results.There was no report of adverse health consequences as a result of discrepant bun results.

Manufacturer Narrative

Original mdr filed (b)(6) 2016.The mdr was filed for the complaint in relation to dimension vista® blood urea nitrogen (bun) updated information communication umdc vc-16-01a.B.Us.The bun lot 16055ab is listed in that communication.Although the root cause of the outliers remains unknown, siemens headquarters service center evaluation of instrument data and service reports indicates that not all the results out of the suspect flex reagent cartridge well set gave discrepant results.The patient sample outliers occurred throughout the well set with several non-impacted samples within the same well set.Quality control recovery was within range before and after this well, however qc was not run on this specific well ((b)(6)).The customer had calibrated on the previous flex and a subsequent well on this flex.The readings all looked steady which would indicate there was not an impacted well.Based on the data provided, siemens remains unable to identify the root cause in this case.However, a customer service engineer was on site several times in the week after this event for various hardware failures.Since then there have been no further issues with discrepant bun results, it is suspected that the issue was resolved by service.

• Brand Name: DIMENSIONVISTA® SYSTEM
• Type of Device: DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5751031
• MDR Text Key: 48307866
• Report Number: 2517506-2016-00257
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/23/2017
• Device Catalogue Number: K1021 SMN 10445159
• Device Lot Number: 16055AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1622-2016
• Patient Sequence Number: 1