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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA® DIMENSION VISTA® CKI CREATINE KINASE FLEX® REAGENT CARTRIDGE

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SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA® DIMENSION VISTA® CKI CREATINE KINASE FLEX® REAGENT CARTRIDGE Back to Search Results
Catalog Number K2038 SMN 10464356
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
Event Type  malfunction  
Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) concerning an absorbance error flagged creatine kinase cki test where a below assay range result was incorrectly reported. The customer did not report issues with any other assays on the instrument. The customer stated that the cki quality control was within laboratory ranges on the date of testing. Siemens headquarters support center (hsc) has reviewed the information provided and instrument data logs and has concluded the investigation. The customer stated that they have not had any issues with any other samples. Hsc review of the data logs showed that the instrument was in good working order during the time of the discrepant cki result and did not show any instrument issues. Hsc reviewed the instrument data for cki and found sample # (b)(6) gave an e141 absorbance error for the cki result. The vista operator's guide instructs the customer that an e141 absorbance error means that the measurement exceeded the photometer's detection limit. The operator's guide also instructs the customer to check the method ifu to determine if the sample can be diluted and, if so, to make the smallest dilution possible to bring the result down into the assay range. The vista cki method can be diluted. The vista cki method has built in auto dilutions of 1:7 and 1:14. According to the information provided by the customer to siemens ccc, the customer stated cki was an add-on test and that the initial cki result was insufficient. The customer then reprocessed the sample for cki separate from the other tests ordered on the sample and received an absorbance error. The customer reprocessed the sample on another vista instrument ((b)(4)) and received an absorbance error. The customer then diluted the same sample from the original vista instrument and processed the diluted sample as id (b)(6) with a 1:7 auto dilution and received a result of 2961 (u/l). The instrument data files did identify the customer runs described. The vista instrument reported all information correctly and at no point did the sample # (b)(6) result a value below assay range. The cause of the discordant cki result is use error. Hsc concluded that the vista instrument and cki reagent is functioning as intended. There is no evidence of a product nonconformance. The device is performing within specifications. No further evaluation is required.
 
Event Description
A discordant, below assay range, creatine kinase (cki) result was reported for a patient sample from a dimension vista 1500 system. The result was provided to the physician. The same sample was reprocessed the same day with a dilution and a higher, correct result was obtained. A corrected report was issued. No treatment was provided to the patient on the basis of the reported discordant cki result. There are no known reports of patient intervention or adverse health consequences due to the discordant cki result.
 
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Brand NameDIMENSION VISTA®
Type of DeviceDIMENSION VISTA® CKI CREATINE KINASE FLEX® REAGENT CARTRIDGE
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
500 gbc drive
po box 6101
newark DE 19714 6101
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
500 gbc drive
po box 6101
newark DE 19714 6101
Manufacturer Contact
james morgera
500 gbc drive
po box 6101
newark, DE 19714-6101
3026318356
MDR Report Key8053079
MDR Text Key128594528
Report Number2517506-2018-00628
Device Sequence Number1
Product Code CGS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2019
Device Catalogue NumberK2038 SMN 10464356
Device Lot Number18100BE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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