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

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional 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.The samples were properly collected and handled at the time of the event.Siemens is investigating the issue.Mdrs 9610806-2021-00002, 9610806-2021-00003, and 9610806-2021-00004 were filed for the discordant results obtained on (b)(6) 2020, respectively.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results were obtained on multiple patient samples from the same patient over several days on a sysmex cs-2500 system using dade innovin reagent.The discordant, falsely elevated results were generated after the patient began receiving vitamin k therapy.Prior to receiving vitamin k therapy, the patient had been tested for pt and inr using the same system and reagent, recovering acceptably.On the second day of receiving vitamin k therapy, a discordant, falsely elevated pt result and a discordant falsely elevated inr result were generated and reported to the physician(s), who questioned the results.A new sample from the same patient was then run in micro mode, recovering lower.The following day, another sample from same patient was run for pt and inr, both recovering high.On the same day, another sample from the same patient was run for pt and inr using a non-siemens system and a non-siemens reagent, resulting lower.The next day, a new sample from the same patient was run on the sysmex cs-2500 system using dade innovin reagent, recovering high.The following day, after stopping vitamin k therapy, a new sample from the same patient was run for inr using another non-siemens system and a non-siemens reagent, resulting lower.Thirteen days later, five samples from the patient were tested for pt and inr on the sysmex cs-2500 system using dade innovin reagent.It is unknown if the results generated at this time were considered discordant.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00005 on 06-jan-2021.Additional information ((b)(6) 2021): quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.Siemens cannot rule out the patient's clinical condition, the effects of the patient's medication, or pre-analytical factors such as sample integrity issues as potential causes of the event.The interferences and limitations of the non-siemens assays are unknown.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Supplemental mdrs 9610806-2021-00002_s1, 9610806-2021-00003_s1, and 9610806-2021-00004_s1 were also filed for the additional information obtained on (b)(6) 2021.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11125935
• Report Number: 9610806-2021-00005
• Device Sequence Number: 17248798
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549759A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR