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

Model Number	DADE INNOVIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) initially recovered within acceptable range on the day of the event.Qc was then run again eight hours later on the same day, at which time the qc did not recover within acceptable range.The customer reconstituted a new vial of the same lot of dade innovin reagent, after which the qc recovered within acceptable range.Siemens is investigating the issue.
Event or Problem Description
Four discordant, falsely low prothrombin time (pt) results were obtained on four different patient samples on a sysmex ca-660 system using dade innovin reagent.The discordant results were reported to the physician(s).Each of the four samples was repeated twice for pt on the same day, recovering higher.Two of the four patient were redrawn the following day and run for pt, also resulting higher.All of the repeat results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low prothrombin time (pt) results.
Additional Manufacturer Narrative
The initial mdr 9610806-2020-00029 was filed on 23-jun-2020.Additional information (24-jun-2020): siemens requested the list of medications taken by the patients, but the customer declined to provide the information.Sample handling and reagent handling were discussed with the customer.No sample integrity issues were reported.The customer reconstitutes the dade innovin reagent and pours over an aliquot into a gw5 vial for the system.The customer leaves the dade innovin reagent on board the analyzer.The reconstituted vial of dade innovin reagent remains in the refrigerator and is not used past the 10 day instructions for use (ifu) stability requirement.Reagent handling cannot be excluded as a potential cause of the issue.Quality controls (qc) recovered outside of acceptable range and did not come back into range until fresh dade innovin reagent was reconstituted.There were no mechanical errors, and acceptable precision indicates that the instrument was performing acceptably.The cause of the discordant, falsely low prothrombin time (pt) results in 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
• MDR Report Key: 10184601
• Report Number: 9610806-2020-00029
• Device Sequence Number: 16365599
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/20/2020

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
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1