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

Catalog Number OPBP035

Device Problem High Test Results (2457)

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

Event Date 12/17/2014

Event Type  malfunction  

Event Description

A falsely depressed d-dimer result was obtained on a patient sample.The result was reported to the physician.The sample was repeated and elevated results were obtained.A corrected result was issued.It is unknown if patient treatment or diagnosis was altered on the basis of the falsely depressed d-dimer result.There was no report of adverse health consequences as a result of the falsely depressed d-dimer result.

Manufacturer Narrative

The cause of the biased low d-dimer results is user error.The user incorrectly input the unit conversion factor during a 12-17-2014 calibration.The issue was corrected by the correct calibrator value input (1000 versus the incorrect 100).The customer stated that there were unaware of any negative effect on patient outcome/treatment.However, they were conducting patient chart reviews.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: INNOVANCE(R) D-DIMER
• Type of Device: INNOVANCE(R) D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 4571740
• MDR Text Key: 21241672
• Report Number: 9610806-2015-00003
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 02/08/2015

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: 07/13/2016
• Device Catalogue Number: OPBP035
• Device Lot Number: 44359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2015
• Initial Date FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1