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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM PROTEIN C

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM PROTEIN C Back to Search Results
Model Number BERICHROM PROTEIN C
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2018
Event Type  Malfunction  
Manufacturer Narrative

The customer contacted a siemens customer care center and reported that different protein c results were obtained on two patient samples using the berichrom protein c reagent. Siemens reviewed the sysmex cs-5100 system back up files and determined that the customer is not using the most recent berichrom protein c application on the sysmex cs-5100 system. The software application used by the customer may not feature re-dilution and it is possible that the customer manually diluted the samples prior to repeating the samples. There is no indication of a software or reagent malfunction and siemens determined that an issue with the manual dilution of the samples potentially contributed to the different protein c results. The sysmex cs-5100 system instructions for use indicates that when results are flagged with error code 0000. 4000. 0041 [extrapolation boundary over (upper)], the operator should change the dilution ratio and repeat the analysis. The reagent is performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2018-00117 was filed for the result obtained on (b)(6) 2018 for sample id (b)(6).

 
Event Description

Flagged non-numerical protein c results were obtained on two patient samples on a sysmex cs-5100 system, using the berichrom protein c reagent. The flagged result for sample id (b)(6) was reported to the physician(s), and it is unknown if the flagged result for sample id (b)(6) was reported to the physician(s). The samples were diluted in a 1:4 dilution and repeated on the same system, using the same reagent lot, resulting in numerical protein c results. The repeat result for sample id (b)(6) was reported to the physician(s). On (b)(6) 2018, sample id (b)(6) was repeated again on the same system and reagent lot, resulting higher than the repeat result. The correct result for either patient is unknown. There are no known reports of patient intervention or adverse health consequences due to the different protein c results.

 
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Brand NameBERICHROM PROTEIN C
Type of DeviceBERICHROM PROTEIN C
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 Key8189356
MDR Text Key131935974
Report Number9610806-2018-00116
Device Sequence Number1
Product Code GGP
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK890634
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 12/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/22/2020
Device MODEL NumberBERICHROM PROTEIN C
Device Catalogue Number10446499
Device LOT Number48671
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
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

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