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

Catalog Number K1021 SMN 10445159

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the qc discrepant results is unknown.The account resolved the issue after instrument server 2 maintenance and recalibration.However, the pattern of low qc followed by high qc after recalibration is suggestive of vista bun field communication vc-16.01.A.B.Ous which involved reagent lot 16055ab.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 (umdc) 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.The account acknowledged receipt of the umdc communication.In a umdc update information - resolution communication sent to the customers dated july 22, 2016, siemens healthcare diagnostics communicated that investigation indicates loss of activity of the gldh enzyme reagent from specific mold cavities caused the issue.Not all flexes or well sets are impacted.Siemens has implemented additional pre-release testing for all vista bun flex reagent lots.The additional testing ensures acceptable lot performance including gldh activity.Beginning with dimension vista bun flex lot 16110ac (expiration date 2017-04-19), and including all subsequent lots that expire thereafter, customers will no longer be required to follow directions in umdc letters vc-16-01.B.Us and vc-16-01a.B.Us or the corresponding urgent field safety notices vc-16-01.B.Ous and vc-16-01a.B.Ous.The letter advised customers that once the laboratory has secured new inventory, they must discard older inventory.Starting with vista bun lot 16110ac, they may restore the normal use of vista bun flex reagent cartridges.It has been confirmed that the customer had received the siemens communications.The account resolved the issue after instrument server 2 maintenance and recalibration.

Event Description

The customer noted discrepant low bun qc results on the dimension vista flex(r) system.No patient samples were run while qc was out of laboratory range.The account recalibrated and qc recoveries were then elevated above the laboratory ranges.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.

• Brand Name: DIMENSION VISTA® 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: 5939647
• MDR Text Key: 54328964
• Report Number: 2517506-2016-00324
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: BF
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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: 08/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1622-2016
• Patient Sequence Number: 1