MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number DADE INNOVIN

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The sample was repeated a second time for pt and inr, recovering lower.The sample was repeated a third time for pt and inr, recovering lower than both of the previous two runs.The sample was then respun and was repeated a fourth time for pt and inr, recovering lower than the three previous runs.The pt and inr results from the third run were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The issue was limited to one patient sample.The customer suspects that the issue is sample specific.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00079 on 30-dec-2021.Additional information (05-jan-2022): the customer declined to provide further information such as patient printouts, quality control (qc) results, sample handling and centrifugation procedures, and patient medications.The customer stated that they believe the issue was sample specific and not an instrument issue.Inadequate sample collection, mixing, centrifugation or other mishandling of the sample cannot be ruled out as contributing factors to the flagged results.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DADE INNOVIN
• Type of Device: DADE INNOVIN
• 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 10591 ; 9144153450
• MDR Report Key: 13118266
• MDR Text Key: 290460869
• Report Number: 9610806-2021-00079
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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: 10/29/2023
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 549788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/25/2022
• 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