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

Model Number DADE INNOVIN

Device Problem High Test Results (2457)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse checked instrument temperatures, which were in range.The cse also ran a precision study for prothrombin time, which recovered acceptably.Qc was run after the service visit and recovered in range.Inadequate mixing, centrifugation or other mishandling of the sample cannot be excluded contributing factors to the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely elevated prothrombin time (pt) result and a discordant, falsely elevated prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant results were reported to the physician(s) and were questioned.Prior to obtaining the discordant results, the patient sample was run for pt and inr, generating a "no coagulation" error and no numeric results.After the physician(s) questioned the results, the patient was redrawn, and the redrawn sample was run for pt and inr, recovering lower.The first sample was then repeated for pt and inr, also recovering lower.Both the first sample and the redrawn sample were then run for pt and inr on an alternate sysmex ca-660 system, also recovering lower.The pt inr results obtained from the redrawn sample on the alternate sysmex ca-660 system 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 discordant, falsely elevated pt and inr results.

• 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: 11557268
• MDR Text Key: 262221446
• Report Number: 9610806-2021-00028
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2021
• 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
• Patient Age: 44 YR