MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH COAGULATION FACTOR VIII DEFICIENT PLASMA

Catalog Number	10446411
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	12/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has determined that the cause of the discordant coagulation factor viii deficient plasma patient results generated on the bcs xp analyzer sn (b)(4) was due to a reagent syringe that required replacement on the system.Once the reagent syringe was replaced, the coagulation factor viii deficient plasma test was rerun on the bcs xp analyzer sn (b)(4) and the results generated were acceptable.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant coagulation factor viii deficient plasma patient results for one patient were generated on the bcs xp analyzer (sn (b)(4)).These results were not reported to the physician.All quality control (qc) was in range on this bcs xp analyzer.The same patient sample was repeated on the same bcs xp analyzer and discordant coagulation factor viii deficient plasma patient results were generated once again.No discordant results were reported to the physician.The same patient sample was then run on a ca-7000 analyzer and on a different bcs xp analyzer (sn (b)(4)).The coagulation factor viii deficient plasma patient results generated on the ca-7000 analyzer were not considered discordant (mean of 34.2%) and consistent with the patient results generated on the bcs xp analyzer sn (b)(4) (mean of 33.2%).The coagulation factor viii deficient plasma patient result generated on the bcs xp analyzer sn (b)(4) (mean of 33.2%) was reported to the physician.There are no reports of patient intervention or adverse health consequence due to the discordant coagulation factor viii deficient plasma patient results.

• Brand Name: COAGULATION FACTOR VIII DEFICIENT PLASMA
• Common Device Name: COAGULATION FACTOR VIII DEFICIENT PLASMA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7165793
• Report Number: 9610806-2018-00003
• Device Sequence Number: 11137301
• Product Code: GJT
• UDI-Device Identifier: 00842768010996
• UDI-Public: 00842768010996
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K924396
• 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): 01/04/2018

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: 10/20/2018
• Device Catalogue Number: 10446411
• Device Lot Number: 547642A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1