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 Problem Low Test Results (2458)

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

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicates that the cause for the falsely depressed 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

Falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista instrument.Patient results were reported to physicians who questioned the results.The samples were repeated on the alternate vista instrument and higher results were obtained.Corrected results were issued.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 2517506-2016-00284 was filed july 27, 2016 a siemens headquarters support center (hsc) specialist reviewed the instrument data, which indicated quality control (qc) was within range on the day of the discrepancy.The cause of the discordant, falsely low calcium (ca) result on one patient sample is unknown.However, a siemens customer service engineer (cse) reviewed the calcium result monitor and determined reagent (r1) blank to be high.The customer was directed to replace the reagent 5 probe, clean the drain, and re-run quality controls.The issue was resolved by replacing the reagent 5 probe and cleaning the drains and no further below assay range flags were obtained.The issue was resolved.The instrument is performing according to specifications.No further evaluation of the device is required.

• 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: 5827894
• MDR Text Key: 50653760
• Report Number: 2517506-2016-00284
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• 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: 09/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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