MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR

Model Number DIMENSION VISTA 500

Device Problems Mechanical Problem (1384); Low Test Results (2458)

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

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse calibrated the calcium assay with a new reagent calibrator lot.During a follow-up visit, the cse ran service methods and found that the sample 1 (s1) overmix was on the lower end.The cse replaced the s1 mixer and auto-aligned the s1.The cse also replaced the reagent 1 (r1) and reagent 2 (r2) probes and auto-aligned them.The cse ran quick checks, service methods and quality controls, all of which were within specifications.The cause of the discordant, falsely low calcium result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low calcium (ca) result was obtained on one patient sample on a dimension vista 500 instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument and on an alternate dimension vista instrument, resulting higher both times.It is unknown if the repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low calcium result.

Manufacturer Narrative

The initial mdr 1226181-2015-00646 was filed on november 19, 2015.Additional information (12/04/2015): a siemens headquarters support center (hsc) specialist reviewed the instrument data and determined that there were multiple water purification module motor voltage error codes, indicative of a clogged inlet filter.Based upon this finding, a siemens customer service engineer (cse) specialist was re-dispatched to the customer site.Upon the cse specialist's suggestions, the customer changed the proguard water filter and reset the instrument.The customer did not see any additional errors.The cause of the discordant, falsely low result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 1226181-2015-00646 was filed on november 19, 2015.The first supplemental mdr 1226181-2015-00646_s1 was filed on december 21, 2015.Additional information (09/15/2016): siemens healthcare diagnostics has confirmed that dimension vista® chem 1 cal lots 5gm081 (kc110) and 5gm082 (kc110b) may produce depressed results with some lots of calcium (ca) flex reagent cartridges.Siemens issued an urgent medical device recall communication to all customers who purchased lot 5gm081 and 5gm082 advising them to recalibrate with an alternate lot of chem 1 cal if they had an active ca calibration.The urgent medical device recall letter vc-16-06.A.Us and urgent field safety notice vc-16-06.A.Ous were dated september 19, 2016 and september 2016, respectively.

• Brand Name: DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR
• Type of Device: DIMENSION VISTA® CHEMISTRY 1 CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive, po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5237689
• MDR Text Key: 31659621
• Report Number: 1226181-2015-00646
• Device Sequence Number: 1
• Product Code: JIX
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: DIMENSION VISTA 500
• Device Catalogue Number: KC110B
• Device Lot Number: 5GM082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2517506-09-28-2016-003-R
• Patient Sequence Number: 1