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

Catalog Number	10445706
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the cause of the discordant prothrombin time (pt) / international normalized ratio (inr) patient results and out of range pt quality control (qc) generated on the sysmex ca-620 system and determined that it was due to an incorrect setting in the pt test protocol.Correction to the test protocol resolved the qc issue.The differences observed for the pt in seconds between the 2 labs can be further explained by a difference in the systems and lot numbers of reagents being used.The inr was developed to correct for the variation that can be seen with pt values reported in seconds between different lots and types of thromboplastin products and analyzer systems.The pt inrs were comparable between the 2 labs.Siemens determined that there is no evidence of a reagent, instrument or software malfunction.The cause of the discordant pt results was due to a use error.The customer service engineer (cse) changed the protocol back to "pt inn", adjusted the detector well temperature and ran quality control (qc) without issue.No further evaluation of this device is required.The systems and reagents are performing according to specifications.Mdr 9610806-2018-00056 was filed for the aptt patient results using dade actin fsl activated ptt reagent lot 556912.
Event or Problem Description
Multiple discordant prothrombin time (pt) patient sample results were generated on a sysmex ca-620 system (serial number (b)(4)) and reported to physicians for using dade innovin lot 539388 when quality control (qc) for pt was out of range.Some patient samples were run for activated partial thromboplastin time (aptt) using dade actin fsl activated ptt reagent lot 556912.On the following day ((b)(6) 2018), all patient samples were retested at an alternate laboratory on a sysmex cs-2500 system, using dade innovin lot 549704 and dade actin fsl activated ptt reagent lot 556904.No corrected reports were issued to physicians.There are no reports of patient intervention or adverse health consequences due to the discordant pt/ inr patient results.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7666404
• Report Number: 9610806-2018-00055
• Device Sequence Number: 1980196
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 07/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2019
• Device Catalogue Number: 10445706
• Device Lot Number: 539388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1