MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 500

Device Problem Mechanical Problem (1384)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse ran service methods, indicating that reagent probe 1 (r1) and reagent probe (r2) were misaligned from the bottom of cuvette.The cse performed bottom of cuvette correction and aligned mix and fluidics, after which service methods came back nominal.The cse ran quick check which passed.The cse performed patient correlation analysis between two dimension vista instruments (serial number (b)(4)), and both yielded near-identical results.The cause of the discordant, falsely low ca result 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 twice on different alternate dimension vista instruments ((b)(4)), resulting higher and matching the patient condition.The repeat result on the first alternate dimension vista instrument result was reported to the physicians(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ca result.

Manufacturer Narrative

The initial mdr 1226181-2016-00271 was filed on june 1, 2016.Additional information (06/03/2016): on 06/03/2016, the cse went to the account to address ongoing calcium (ca) and glucose (glu) abnormal assay errors.The cse verified readings of service methods after alignment, which resulted acceptable.The cse cleaned drains and checked for proper vacuum.The cse verified proper performance of all air knifes and checked health report for any trends.The cse performed a total service visit.The cse ran quick check and quality control (qc), resulting satisfactory.A siemens headquarters support center (hsc) reviewed the complaint for discrepant calcium results and observed multiple "kin check" errors at the time the data was accessed on (b)(6) 2016.Review of the calculation data shows several results in the data set are above the customer "kin check" mean of 103.74."kin check" values vary from 99.85 - 108.77.The standard deviation is 0.46."kin check" check errors indicate an issue with sample mix.Typical kin check standard deviation is around 0.20.The ca blank and r1 blank data are not indicating any issue with calcium contamination or reagent delivery issues.The cause of the discordant, falsely low ca result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEATHCARE DIAGNOSTICS INC.; 101 silvermine reoad; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5692802
• MDR Text Key: 46365640
• Report Number: 1226181-2016-00271
• Device Sequence Number: 0
• Product Code: CIC
• 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
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2012
• 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