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

Catalog Number OPBP035

Device Problem Low Test Results (2458)

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

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Biased low results d-dimer results were obtained on qc and patient samples.Patient results were reported to the physician.After it was determined that a calibration had been in place when an incorrect calibrator value had been used, patient samples recovered higher results.There is no indication that patient treatment or diagnosis was altered on the basis of the biased low d-dimer results.There was no report of adverse health consequences as a result of the biased low d-dimer results.

Manufacturer Narrative

The cause of the biased low d-dimer results is user error.The user incorrectly input the calibrator value during a (b)(6) 2014 calibration.The issue was corrected by recalibration of the assay with the correct calibrator value input.The customer called siemens back and stated the pathologist has reviewed all patients affected and determined that there were no re-admission, no re-tests, no results questioned by treating physicians, and no suspicion of any negative effect on patient outcome/treatment.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: 3731670
• MDR Text Key: 4272838
• Report Number: 9610806-2014-00016
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/14/2014
• Device Catalogue Number: OPBP035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1