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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 Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2020
Event Type  malfunction  
Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls failed, after which the customer noticed they did not remove the rinse float from the barbicide container after performing tube disinfection on their bcs xp system.The customer set the rinse float back in the rinse bottle, replaced the reagents, and performed rinses.Quality controls were then rerun and recovered within acceptable ranges.The instrument is now fully operational.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.
 
Event Description
A discordant, falsely low d-dimer result was obtained on a bcs xp system using innovance d-dimer reagent.The discordant result was reported to the physician(s).The same sample was repeated for d-dimer two times on an alternate bcs xp system, once using the d-dimer low application and once using the d-dimer high application.Both results recovered higher than the initial discordant result.The patient was redrawn and the redrawn sample was run for d-dimer on the same alternate bcs xp system, once using the d-dimer low application and once using the d-dimer high application.Both results recovered higher than the initial discordant result.The higher 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 d-dimer result.
 
Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00049 on 06-oct-2020.Additional information (06-oct-2020): section d8 of the mdr was changed from "unknown" to "no".
 
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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
MDR Report Key10635771
MDR Text Key214805553
Report Number9610806-2020-00049
Device Sequence Number1
Product Code GKP
UDI-Device Identifier00630414945514
UDI-Public00630414945514
Combination Product (y/n)N
PMA/PMN Number
K970431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/20/2020
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
Device Operator Health Professional
Device Model NumberBCS XP SYSTEM
Device Catalogue Number10459330
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received10/06/2020
Supplement Dates Manufacturer Received10/06/2020
Supplement Dates FDA Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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