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

Model Number 10445159

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Low Test Results (2458)

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

Event Date 01/10/2016

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 offered a no charge replacement or credit for discarded inventory.

Event Description

The customer noted discrepant bun qc and patient results within a dimension vista flex(r) reagent cartridge well set.After a shift downward with an impacted well the customer recalibrated with the impacted well and later result shifted upward with a non-impacted well.Patient results were reported to physicians.Corrected reports were issued.There is no indication that patient treatment was altered or prescribed on the basis of discrepant low bun results.There was no report of adverse health consequences as a result of the discrepant low bun results.

Manufacturer Narrative

Siemens submitted mdr 2517506-2016-00148 on 3/3/2016.(b)(4).As described in the original mdr submission: there is no indication that patient treatment was altered or prescribed on the basis of discrepant low bun results.There was no report of adverse health consequences as a result of the discrepant low bun results.

Manufacturer Narrative

(b)(4).

• Brand Name: DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE
• 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: 5477351
• MDR Text Key: 39641928
• Report Number: 2517506-2016-00148
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/30/2016
• Device Model Number: 10445159
• Device Catalogue Number: K1021
• Device Lot Number: 15243BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2517506-02-26-2016-002-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other