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

Model Number INNOVANCE D-DIMER

Device Problem Low Test Results (2458)

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

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.Mdr 9610806-2020-00017 was filed for the discordant d-dimer result obtained on 10-apr-2020.

Event Description

Discordant, falsely low d-dimer results were obtained on a patient sample on two different sysmex ca-1500 systems using innovance d-dimer reagent.When the patient sample was initially run for d-dimer on a sysmex ca-1500 system using innovance d-dimer reagent, the system generated a "range over" error code and did not give a result.The sample was repeated for d-dimer on the same system with the same reagent, recovering above the lab's d-dimer cutoff.This result was considered correct and was reported to the physician(s).The sample was then repeated for d-dimer on the same system with the same reagent, recovering below the cutoff.This result was considered discordant and was not reported to the physician(s).The following day, the same sample was repeated for d-dimer on an alternate sysmex ca-1500 system using d-dimer reagent, which also recovered below the cutoff.This result was also considered discordant and was not reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00016 on 06-may-2020.Additional information (18-may-2020): siemens healthcare diagnostics inc's investigation has determined that quality controls (qc) recovered within range at the time of the event.Precision was acceptable and there were no problems with any other samples.Inadequate mixing, centrifugation or other mishandling of the sample cannot be excluded as contributing factors to the discrepant results.The customer has been educated on the appropriate troubleshooting steps should an instance like this occur in the future.The customer is operational.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00017_s1 was filed for the same issue.

• 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
• MDR Report Key: 10028723
• MDR Text Key: 191181831
• Report Number: 9610806-2020-00016
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (y/n): N
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 49072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR