MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER

Catalog Number SMN10445980

Device Problem Low Test Results (2458)

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

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the discrepant falsely depressed d-dimer result is unknown.However, analysis of the instrument data revealed no systematic failures or qc failures.The issue is an isolated observation of a patient measurement with a falsely low d-dimer result in a single determination which is discordant to other measurements.The cause of the issue seems to be related to the affected 2nd sample.This sample is described as having a high count of fibrin monomers.Fibrin monomers are an intermediates in the fibrinogen activation to fibrin and may cause microclots.Samples with microclots may cause sample under-aspiration by pipettor clogging and by this may deliver false low results.Microclots can be removed by correct sample preparation with centrifugation, and therefore the presence of microclots is a preanalytical issue which is under the user's responsibility.In addition, as the patient has a known malignancy suspected for dic/sepsis, the results of such samples have to be interpreted with caution as these disease stages are known to potentially interfere with d-dimer analysis as indicated in the 'summary and explanation' section of the instructions for use.The device is performing within specifications.No further evaluation of the device is required.

Event Description

A discrepant low d-dimer result was obtained on a patient sample on the cs-5100 instrument.The result was not reported to the physician.The same sample was retested and a higher result was obtained and reported.There is no indication that patient treatment was altered or prescribed on the basis of the discrepant low d-dimer result.There was no report of adverse health consequences as a result of the discrepant low d-dimer result.

• Brand Name: INNOVANCE D-DIMER
• Type of Device: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6089858
• MDR Text Key: 59509445
• Report Number: 9610806-2016-00034
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2016

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: Health Professional
• Device Expiration Date: 10/11/2017
• Device Catalogue Number: SMN10445980
• Device Lot Number: 45736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2015
• 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
• Patient Age: 62 YR