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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 Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
The customer contacted a siemens customer care center (ccc); the customer asked which international sensitivity index (isi) value should be used on a laboratory information system (lis) when calculating international normalized ratio (inr) results.The customer reported that since (b)(6) 2019, they reported patient results using the incorrect isi result and indicated that they will gather patient results that were tested in that time period.On (b)(6) 2019, the customer provided the results in mdr 9610806-2019-00015.The cause of the event was a use error.There was no instrument malfunction.The customer is aware of the instrument's labelling.The customer corrected the isi value on the lis.The instrument is performing according to specifications.No further evaluation of this device is required.
 
Event Description
The customer reported that they used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results for multiple patient samples on a bcs xp system.The customer used the isi value of 0.93 to calculate patient samples inr results instead of the isi value of 1.09.The customer indicated that since (b)(6) 2019, they reported patients' inr results using the incorrect isi value for 3 weeks; as per the customer 26 patients (44 samples) were impacted by this issue.However, the customer did not identify which patients were impacted.The correct inr results were reported to the physician(s).There was no report of patient intervention or adverse health consequences due to the customer using the incorrect international sensitivity index (isi) value to calculate inr results for patient samples.
 
Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00015 on 08- march-2019.Additional information (20-feb-2019): as per siemens communication to customers in december of 2012, when customers rollover to a dade innovin reagent lot, customers are instructed to contact the siemens technical solutions center to obtain the correct isi to be updated in the lis.The customer indicated that they are aware of this communication, contacted siemens, and siemens provided a letter to the customer (dated 15-jan-2019) with the correct isi value to use for their dade innovin reagent lot (549722).As per siemens instructions, the customer updated the isi result in their lis.Siemens further investigated the issue and determined that there was no instrument or reagent malfunction; the bcs xp system evaluated the results correctly and the results were correctly transmitted to the lis.A use error contributed to the incorrect pt inr results.Corrected information (14-march-2019): the initial mdr indicated that " as per the customer 26 patients (44 samples) were impacted by this issue".Upon further investigation, the number of impacted patient samples is 41.No further investigation is required.Mdrs 9610806-2019-00016, 9610806-2019-00017, 9610806-2019-00018, 9610806-2019-00019, 9610806-2019-00020, 9610806-2019-00021, 9610806-2019-00022, 9610806-2019-00023, 9610806-2019-00024, 9610806-2019-00025, 9610806-2019-00026, 9610806-2019-00027, 9610806-2019-00028, 9610806-2019-00029, 9610806-2019-00030, 9610806-2019-00031, 9610806-2019-00032, 9610806-2019-00033, 9610806-2019-00034, 9610806-2019-00035, and 9610806-2019-00036 were filed for the same issue.
 
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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 Key8406029
MDR Text Key140625475
Report Number9610806-2019-00015
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 03/19/2019
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 02/06/2019
Initial Date FDA Received03/08/2019
Supplement Dates Manufacturer Received02/20/2019
Supplement Dates FDA Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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