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

Model Number INNOVANCE D-DIMER KIT

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

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) application specialist analyzed the sysmex cs-2100i backup files to determine the cause of the discordant d-dimer (ddi) results.Siemens performed a linearity test with the affected patient sample and the sample did not show linearity.This is a sample specific issue.The instrument and the reagents are performing according to specifications.No further evaluation of this device or reagent is required.The innovance d-dimer reagent described is not marketed in the us and the pma/510(k) number in section g5 is for the us specific kits.The reagents marketed in the us have (b)(4).

Event Description

Discordant d-dimer results were obtained on 2 samples from the same patient on the sysmex cs-2100i system using the innovance d-dimer kit.The operator ran a patient sample for d-dimer (ddi) on the sysmex cs-2100i system and obtained a flagged ddi result 7.12 mg/l.The result was flagged with hemolytic sample and lipemic sample.This result was reported to the physician.The operator re-ran the same patient sample on the same sysmex cs-2100i system and obtained a ddi result of 7.39 mg/l.The result was flagged with error messages: hemolytic sample, lipemic sample, and defective sample volume.The instrument automatically diluted the same patient sample by 1/8 and a non-numerical (---.--) flagged result was obtained.The 1/8 diluted patient sample was flagged with error messages: hemolytic sample, lipemic sample, defective sample volume, dilution ratio was changed, and extrapolation boundary over (lower).The "extrapolation boundary over (lower)" flag indicates a result below clinical cut-off (i.E.<0.19 mg/l).The operator manually diluted the same patient sample by ½ and re-ran the sample on the same sysmex cs-2100i system.A ddi result of 1.96 mg/l was obtained.The patient blood was re-drawn to eliminate any pre-analytical issue with the original specimen and re-run on the same sysmex cs-2100i system.A flagged ddi result of 10.45 mg/l was obtained for this re-drawn patient sample.The result was flagged with error messages: hemolytic sample, lipemic sample, and defective sample volume.The instrument automatically diluted the same re-drawn patient sample by 1/8 and a non-numerical (---.--) flagged ddi result was obtained.The 1/8 diluted patient sample was flagged with error messages: hemolytic sample, lipemic sample, defective sample volume, dilution ratio was changed, and extrapolation boundary over (lower).The operator stated that the specimens were correctly filled and the volume flags are only seen because the operator re-ran the specimen multiple times.Both, original and re-drawn, samples have hemolytic flags but the operator stated that both samples did not appear hemolytic nor lipemic.Only the initial ddi result of 7.39 mg/l was reported to the physician.The correct result is unknown.There are no known reports of patient intervention or adverse health consequences due to the discordant d-dimer results.

• 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: elizabeth bernasconi ; 511 benedict ave; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 6647462
• MDR Text Key: 77870281
• Report Number: 9610806-2017-00063
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/16/2017

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 KIT
• Device Catalogue Number: 10445979 (SEE SECTION H10)
• Device Lot Number: 46914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/16/2017
• 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