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

Model Number INNOVANCE D-DIMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

The operator did not provide any clinical presentation, disease or symptom information for this patient and siemens healthcare diagnostics inc.Is not aware of any patient harm caused by the discordant results.It is unknown whether the patient is truly positive or negative.The cause of the discordant d-dimer (ddi) results cannot be determined and is unknown.The operator from the alternate facility, (b)(6), indicated that the stratus cs 200 analyzer d-dimer results were correct and there is no indication the stratus cs 200 analyzer did not perform as intended.There is no supporting patient information that the correct d-dimer result should be positive, as the operator indicated.An individual false positive result on the stratus cs 200 would not be an indication that the assay/analyzer is, in general, not performing as intended since d-dimer assays are typically used as an exclusion marker for dvt (deep vein thrombosis) / pe (pulmonary embolism).For this purpose, the respective assays have a high sensitivity with a remarkably lower specificity.No further evaluation of this device was performed.

Event Description

A positive d-dimer (ddi) result was obtained on a patient sample on the stratus cs 200 analyzer at (b)(6).Based on this positive ddi result, the patient was referred to the (b)(6) hospital for an urgent treatment.The patient blood was re-drawn and run at the (b)(6) hospital.A negative ddi result was obtained on the bcs xp system and reported to the physician.The patient was sent home based on the negative ddi result obtained on the bcs xp system.There are no reports of patient intervention or adverse health consequences due to the discordant ddi result.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2017-00070) on july 14, 2017.July 17, 2017 additional information: the lot number of the affected innovance d-dimer kit was 46913.This kit expires on october 23, 2018 and the di number for this product is 00842768020117.The reagent is not marketed in the us.The similar reagents that are marketed in the us have catalog numbers: 10445981 and 10445982 and the pma/510(k) for the reagent registered in the us is k093626.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00070 on july 14, 2017.Supplemental mdr 9610806-2017-00070-s1 was filed on july 24, 2017.Corrected information (july 26, 2017): upon further investigation, siemens determined that the date that siemens became aware of the issue on the bcs xp system was on june 7, 2017 and not on may 11, 2017, as originally reported in mdr 9610806-2017-00070.Date rec¿d by mfr reflects the date that siemens received this corrected information.

• Brand Name: INNOVANCE D-DIMER
• Type of Device: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; D-350 41; GM D-35041
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict ave; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 6714892
• MDR Text Key: 80076187
• Report Number: 9610806-2017-00070
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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,Followup,Followup
• Report Date: 08/25/2017

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: 10/23/2018
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445980 (SEE SECTION H10)
• Device Lot Number: 46913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 07/26/2017
• Supplement Dates FDA Received: 07/24/2017; 08/25/2017
• Was Device Evaluated by Manufacturer?: No
• 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