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

Model Number INNOVANCE D-DIMER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range and no instrument errors occurred at the time of the event.The issue was isolated to these patient samples from the same patient only.Siemens explained to the customer that for future samples the customer should perform either a 1/2 or 1/4 offline manual dilution using d-dimer diluent to confirm the result.The cause of the discordant result(s) is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A d-dimer result was obtained on a patient sample on a sysmex ca-660 system using innovance d-dimer reagent.The customer reran the sample for d-dimer using the d-dimer+ (ddi+) application with the same system and reagent, recovering lower.A second sample from the same patient was run for d-dimer using the same system and reagent, recovering higher.The redrawn sample was repeated again for d-dimer using the ddi+ application with the same system and reagent, recovering lower.The higher d-dimer result was reported to the physician(s).It is unknown which d-dimer result was considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer result(s).

• 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; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, ny ; 5242740
• MDR Report Key: 10404576
• MDR Text Key: 202952366
• Report Number: 9610806-2020-00038
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2020

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: 12/01/2021
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 50233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/13/2020
• 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