MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH COAGULATION FACTOR VIII DEFICIENT PLASMA

Catalog Number OTXW17 SMN 10446411

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center questioning the higher results obtained on the bcs xp relative to other non-siemens systems.Siemens headquarters support center (hsc) representatives have evaluated the information provided.Hsc concluded that review of all available information gives no indication of a systemic issue with the bcs xp system, reagent material, or laboratory practices at the customer laboratory.Routine quality control as well as prior survey samples recover acceptably.An overall problem with the fviii % activity application with actin fsl on the bcs xp system can be excluded.Patient comparisons have been conducted and demonstrate acceptable comparison for fviii % activity between the alternate vendor methods (non-siemens).Recovery of the samples fviii % activity on an alternate instrument system with actin fsl reagent and factor viii deficient plasma also was consistent with the bcs xp system recovery.Additionally, comparison across various lots of actin fsl compare well.Comparison of multiple external quality assessment survey vendor samples do not demonstrate a systemic bias.A clear difference in recovery with this specific sample is demonstrated between the application of siemens fviii with actin fsl on the bcsp xp as compared to competitors systems.The patient had received helixate fs product (recombinant factor viii concentrate) prior to collection of this sample.The recovery with siemens products is believed to be accurate for the sample provided to the laboratory for analysis.A false low bias is believed to be demonstrated with the alternate vendor products.The customer has confirmed that no irreparable harm was caused to the patient based upon the original value reported.The device is performing within specifications.No further evaluation of the device is required.

Event Description

A factor viii (fviii) result on a patient sample was questioned as discordant relative to values obtained with alternate reagent methodologies.The sample was tested with coagulation factor viii deficient plasma using the dade actin fsl reagent on the bcs xp instrument.The same sample was sent to alternate laboratories for testing.Lower results were obtained with two alternate non-siemens methodologies on non-siemens instruments.The physician questioned the initial fviii results with the siemens system as discordant with the clinical presentation.Patient did receive fviii concentrate four hours before the testing for fviii was performed.There is no indication that patient treatment was altered or prescribed on the basis of the questioned as discordant fviii result.There was no report of adverse health consequences as a result of the questioned as discordant fviii result.

• Brand Name: COAGULATION FACTOR VIII DEFICIENT PLASMA
• Type of Device: COAGULATION FACTOR VIII DEFICIENT PLASMA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6376100
• MDR Text Key: 69017056
• Report Number: 9610806-2017-00028
• Device Sequence Number: 1
• Product Code: GJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2017

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 Expiration Date: 05/18/2018
• Device Catalogue Number: OTXW17 SMN 10446411
• Device Lot Number: 547633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1