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

Catalog Number OPBP35 SMN10445979

Device Problem Low Test Results (2458)

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

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the biased low d-dimer results is user error.The initial result was flagged and should not have been reported without further investigation.The event involved a patient sample specific issue.Examination of instrument data revealed an artifact at the beginning of measurement that led to a predilution of the sample with a dilution factor of 1:19 causing the falsely depressed result.This unnecessary high dilution led to result inaccuracy.The customer stated that there were unaware of any negative effect on patient outcome/treatment other than no further evaluation for deep vein thrombosis (dvt) or pulmonary embolism (pe).The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A falsely depressed d-dimer result was obtained on a patient sample on the cs-2100i system.The result was flagged for review but reported to the physician.The sample was repeated after ultracentrifugation and a higher result was obtained.Patient treatment was altered on the basis of the falsely depressed d-dimer result.There was no further assessment conducted for deep vein thrombosis (dvt) or pulmonary embolism (pe) due to the falsely depressed result.There was no report of adverse health consequences as a result of the falsely depressed d-dimer result.

• Brand Name: INNOVANCE(R) D-DIMER
• Type of Device: INNOVANCE(R) 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: 5789905
• MDR Text Key: 49394640
• Report Number: 9610806-2016-00022
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 07/13/2016

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: 06/28/2017
• Device Catalogue Number: OPBP35 SMN10445979
• Device Lot Number: 45404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR