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

Model Number	DADE INNOVIN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no hardware errors occurred at the time of the event.A siemens customer service engineer (cse) has been dispatched to the customer site.Siemens is investigating the issue.
Event or Problem Description
Three different prothrombin time (pt) results and three different prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.None of the results were reported to the physician(s).It is unknown which, if any, of the results were considered correct.There are no known reports of patient intervention or adverse health consequences due to the discordant pt and inr results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00078 on 22-dec-2021.Additional information (04-jan-2022): the siemens customer service engineer (cse) could not reproduce the issue.The cse performed all alignments, verified temperatures, and calibrated detectors, with no errors observed.A precision test was run for prothrombin time (pt), which recovered acceptably.Quality controls (qc) recovered in range, no mechanical errors were observed, and no other samples were affected.Inadequate mixing, centrifugation or other mishandling of the sample or reagent cannot be excluded as contributing factors to the discordant 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
• 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
• 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: 13061367
• Report Number: 9610806-2021-00078
• Device Sequence Number: 1609141
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 549755B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown