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 Consequences Or Impact To Patient (2199)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

A falsely depressed d-dimer result was obtained on a patient sample.The patient result was reported to the physician who questioned the result as discrepant with a result obtained with an alternate methodology.The sample was repeated on the original instrument and an elevated result was obtained in line with physician expectations.There is no indication that 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 initial discordant low result is unknown.Investigation of instrument data shows no general problem with assay, and customer is not questioning any qc measurements or other samples.Investigation of repeat testing shows an abnormal pattern: - first repeat measurement gives a range over signal message without indicating a d-dimer value.- repetition with a diluted sample aliquot gives a result of 28.56 mg/l.This result is far below the antigen excess threshold level of 500 mg/l.The affected sample is giving inconsistent results.The patient is suffering from acute promyelocytic leukemia and other findings show a discordant platelet count.We cannot exclude that the sample showed signs of coagulation that interfered with the pipetting of the initial first measurement (by aspirating a fibrin aggregate).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: 4117220
• MDR Text Key: 15123391
• Report Number: 9610806-2014-00025
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 08/29/2014

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: 10/14/2015
• Device Catalogue Number: OPBP035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1