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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event and no instrument errors were observed.Improper centrifugation as well as issues regarding the integrity of the sample collection tubes used cannot be ruled out as potential causes of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2021-00019 and 9610806-2021-00020 were filed for additional discordant results obtained on 27-jan-2021 and 30-jan-2021 on the same bcs xp system.
 
Event Description
Potential falsely low activated partial thromboplastin time (aptt) results were obtained on five different patient samples on a bcs xp system using pathromtin sl reagent.A discordant, falsely elevated prothrombin time (pt) result was obtained on one patient sample on a bcs xp system using dade innovin reagent.A potential discordant, falsely low d-dimer result was obtained on one patient sample on a bcs xp system using innovance d-dimer reagent.The discordant results were not reported to the physician(s).The samples were all repeated for the respective assay and the correct repeat results were reported to the physician(s).The customer did not provide the actual correct result for some of the patient samples.There are no reports of patient intervention or adverse health consequences due to the discordant activated partial thromboplastin time (aptt), prothrombin time (pt), and d-dimer results.
 
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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)
BIT ANALYTICAL INSTRUMENTS GMBH
registration number: 300360107
am kronberger hang 3
schwalbach, 65824
GM   65824
Manufacturer Contact
christopher aebig
511 benedict ave
tarrytown, NY 10591
9144153450
MDR Report Key11382371
MDR Text Key245114710
Report Number9610806-2021-00021
Device Sequence Number1
Product Code GKP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K970431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
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 Number10470625
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2021
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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