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

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.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION 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 Key: 8053079
• MDR Text Key: 128594528
• Report Number: 2517506-2018-00628
• Device Sequence Number: 1
• Product Code: CGS
• UDI-Device Identifier: 00842768027925
• UDI-Public: 00842768027925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083465
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Catalogue Number: K2038 SMN 10464356
• Device Lot Number: 18100BE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2018
• 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