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

Catalog Number	10445706
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the provided information to determine the cause of the discordant prothrombin time (pt)/ international normalized ratio (inr) patient result generated on the sysmex ca-660 analyzer.No other patient samples exhibited the same issue and quality control (qc) was within range at the time of the event.No product non-conformance nor system issue could be identified.A potential cause of the event may be due to sample handling or the nature of the sample.The cause of the discordant prothrombin time (pt)/ international normalized ratio (inr) patient result generated on the sysmex ca-660 analyzer is unknown.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
One patient sample (sample 1) was run on the sysmex ca-660 analyzer which generated a prothrombin time (pt)/ international normalized ratio (inr) result of "no coagulation." this result was reported to the physician and questioned.All quality control (qc) was in range prior to testing.The same sample was run on the same system (sysmex ca-660 analyzer) two (2) more times generating the same pt/inr result ""no coagulation." the same sample was then run on an abbott istat point of care analyzer (non-siemens system) which generated a pt/int result of "no clot detected" and an inr result of >9.0 was reported to the physician.A different sample (sample 2) from the patient was run on the same ca-660 analyzer and a pt/inr result of 25.2 seconds/ inr 2.46 was generated.The same sample was run again on the same sysmex ca-660 analyzer and a similar result was generated.The pt/inr result of 25.2 seconds/ inr 2.46 was reported to the physician as the correct result.Sample 1 was rerun again (3) three more times on the ca-660 analyzer generating pt/inr results similar to results generated by sample 2.There are no reports of patient intervention or adverse health consequences due to the discordant pt/inr patient result.

• 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: 7227159
• Report Number: 9610806-2018-00016
• Device Sequence Number: 19079525
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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: 08/18/2019
• Device Catalogue Number: 10445706
• Device Lot Number: 539394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1