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

Model Number DADE INNOVIN

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Siemens investigated the system backup files provided by the customer and did not find any issue.Siemens determined that maintenance was regularly performed on the system and that quality controls (qc) were within expected ranges on the day of the event.Siemens also determined that the reaction kinetics of the affected measurements were correctly elevated by the system.Siemens concluded that a pre-analytical issue potentially caused the discordant, falsely low pt inr results.The reagent and system are performing according to specifications.No further evaluation of these devices is required.

Event Description

A non-numerical prothrombin time (pt) result of "no coagulation" was obtained on a patient sample on the sysmex cs-2100i system using dade innovin reagent.The initial result was not reported to the physician(s).The patient was re-drawn and the new sample was run on the same system and using the same reagent.The results obtained on the redrawn sample was considered to be correct and the pt international normalized ratio (inr) was reported to the physician(s).The initial sample was repeated on the same system and using the same reagent, resulting in a lower pt and pt inr result and a higher pt % results.The initial sample was also repeated using the same system and same reagent in extended time, resulting in a flagged no coagulation result.There are no known reports of adverse health consequences due to the discordant, falsely low pt inr results.

• Brand Name: DADE INNOVIN
• Type of Device: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7903839
• MDR Text Key: 121718428
• Report Number: 9610806-2018-00099
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

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: 09/01/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539395A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/24/2018
• 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: 79 YR