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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM Back to Search Results
Model Number BCS XP SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2017
Event Type  malfunction  
Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant prothrombin time (pt) results.The cse replaced the disinfectant pump unit, interface p board, hc11d in the interface p board, pelt board, and x-y com cable for both arms and cse adjusted the 5v and 24v supply.The cse restored globals and eeprom parameters and cleared errors.The cse performed diagnostic checks with no issues and ran internal quality controls, which recovered within range.The cause of the discordant results is unknown.The system and reagents are performing according to specifications.No further evaluation of this system is required.
 
Event Description
Discordant, falsely elevated prothrombin time (pt) results were obtained on 9 patient samples on the bcs xp system.These results were reported to the physician(s), who did not question the results.One patient ((b)(4)) was treated with a dose of vitamin k due to the discordant result.The same patient samples were rerun at another facility on an alternate bcs xp system, resulting lower.Corrected reports were provided to the physician(s).A discordant, falsely low pt result was obtained on another patient sample on the same bcs xp system.The result was reported to the physician, who did not question the result.The same patient sample was rerun at the other facility on the other bcs xp system, resulting higher.A corrected report was provided to the physician.There are no known reports adverse health consequences as the customer informed the registered nurse (rn) about the discordant results and advised the rn to not act on the discordant results.The customer indicated that the hospital's internal audit, performed by the quality assurance department, indicated that no adverse patient care or harm occurred.
 
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Brand Name
BCS XP SYSTEM
Type of Device
BCS XP SYSTEM
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
christina lam
511 benedict ave
tarrytown, NY 10591
9145243504
MDR Report Key6904321
MDR Text Key89501920
Report Number9610806-2017-00106
Device Sequence Number1
Product Code GKP
UDI-Device Identifier00630414945514
UDI-Public00630414945514
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/29/2017
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
Device Operator Health Professional
Device Model NumberBCS XP SYSTEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2017
Initial Date FDA Received09/29/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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