MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE; DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE

Catalog Number K1023 SMN 10445160

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

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

Event Date 06/12/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discrepant ca patient results is unknown.Siemens healthcare is investigating calcium (ca) lot 16109bb.The mdr will be updated with the results of the investigation.

Event Description

The customer noted discrepant calcium (ca) results on patient samples on the dimension vista flex(r) instrument relative to recoveries on their other vista.Patient results were not reported to physicians.There is no indication that patient treatment was altered or prescribed on the basis of discrepant ca results.There was no report of adverse health consequences as a result of discrepant ca results.

Manufacturer Narrative

Original mdr filed (b)(6) 2016.New information: a siemens healthcare customer service engineer (cse) visited the site and found evidence of gel material within the instrument sample aliquot system drain.The root cause of the discrepant results appears to be related to the sample handling and pre-analytical variables.The cse replaced the drain and re-aligned the aliquot probe.A system check and precision study was run.

• Brand Name: DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION VISTA® CA CALCIUM 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: 5789708
• MDR Text Key: 49379952
• Report Number: 2517506-2016-00266
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061792
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/18/2017
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 16109BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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