MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® SYSTEM; ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE

Catalog Number K1270A SMN10700444

Device Problem Low Test Results (2458)

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

Event Date 04/03/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discrepant depressed ecrea results is unknown.The complaint involved one individual patient's samples drawn over the course of multiple days.The internal investigation conducted by the account showing repeat results obtained within hours of the initial run on the dimension vista with an alternate siemens instrument system (advia centaur) with a similar methodology is suggestive a sample specific issue peculiar to the one individual patient or with their treatment regimen.Additionally, the customer's study showed that the ecrea results matched the alternate siemens instrument system results when the original samples were rerun several days later.The account requested investigation of whether one drug, dopamine, could be responsible for a transient depression of ecrea results.The siemens headquarters service center evaluated literature and labeling information and found no indication that dopamine or catecholamines would depress creatinine results.In the investigation it was noted that there is some indication that elevated bilirubin can depress ecrea results to some degree.The investigation has been concluded since no fresh samples from the individual sample can be evaluated.The complaint involved only discrepant results on samples from this individual patient from three consecutive days.The discrepancies with the individual patient ecrea results are not seen with more recent samples from the same individual.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discrepant depressed enzymatic creatinine (ecrea) results were obtained on an individual patient's samples over multiple successive samples on the dimension vista system.The results were reported to the physician who eventually questioned the results.The samples were repeated on an alternate siemens instrument (advia centaur) and higher results were obtained.The same samples were tested on the original dimension vista system several days later and higher results were obtained.There is no indication that patient treatment was altered on the basis of the discrepant depressed ecrea results.There was no report of adverse health consequences as a result of the discrepant depressed ecrea results.

• Brand Name: DIMENSION VISTA® SYSTEM
• Type of Device: ENZYMATIC CREATININE 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: 5614741
• MDR Text Key: 43994019
• Report Number: 2517506-2016-00234
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 09/20/2016
• Device Catalogue Number: K1270A SMN10700444
• Device Lot Number: 15294AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR