MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN® SL

Model Number PATHROMTIN® SL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) analyzed the backup data provided by the customer to determine the cause for the differences in aptt results on the affected patient sample.Siemens found no issues with the reaction kinetics on the bcs xp system and determined that the bcs xp system performed as expected.Siemens is investigating the cause of the discordant, falsely elevated results obtained on the sysmex cs-5100 systems.The pathromtin® sl reagent with catalog number 10484200 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific reagents.The pathromtin® sl reagents marketed in the us have catalog numbers 10446066 and 10446067.

Event Description

Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on a patient sample on two different sysmex cs-5100 systems.The discordant aptt results were not reported to the physician.The same patient sample was rerun using an alternate pathromtin sl lot on a bcs xp system, recovering lower.The customer reported the result obtained on the bcs xp system.The physician expected an aptt result in the normal range.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00104 on september 25, 2017.Additional information (september 28, 2017): a siemens headquarters support center (hsc) specialist analyzed the sysmex cs-5100 systems' backup files to determine the cause of the discordant, falsely elevated activated partial thromboplastin time (aptt) results and found no issues.The hsc specialist determined that the official assay protocol was used on both systems and no error codes were observed in the systems' backup files.At the time of the event, the internal quality controls recovered within the tables of assigned values (tavs) ranges on both systems.The cause of the discordant, falsely elevated aptt results is unknown.Updated to reflect the additional information.The systems and reagent are performing according to specifications.No further evaluation of these systems is required.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00104 on 25-sep-2017 and the supplemental mdr 9610806-2017-00104_s1 on 23-oct-2017.Additional information (09-nov-2017): siemens technical support lab (tsl) evaluated both pathromtin sl reagent lots (lot 536695 and lot 536696) on a bcs xp system and a sysmex cs-5100 system.The systems and the reagent lots were evaluated using control plasma n lot 507719, ci-trol 2 lot 548264, and control plasma p lot 509999 for reference purposes.Control plasma n lot 507736 and control plasma p lot 509998 were measured and compared to the assigned ranges as specified by the tables of assigned values (tav's).Fresh frozen plasma was measured as a sample in the normal range and the patient samples provided by the customer were measured to investigate the differences between the systems.The reference control recoveries were found within the assigned ranges as specified by the tav´s, independent of reagent lot measured and the system used.Control plasma n lot 507736 and control plasma p lot 509998 were found within the assigned range as specified by the tav's, independent of reagent lot measured.All measured values were comparable, independent of reagent lot measured and independent of system used.The measured fresh frozen plasma was found within expected ranges according to the reference guide.When siemens measured the patient samples provided by the customer, siemens observed that the results obtained on the bcs xp system recovered significantly lower than the results obtained on the sysmex cs-5100 system.A general problem with the reagents used and general difference between sysmex cs-5100 system and bcs xp system performance could be excluded.All tested quality controls and fresh frozen plasma recoveries were found comparable on sysmex cs-5100 system and bcs xp system, independent of reagent lot used.The observed differences in the patient sample results between both systems are potentially due to a sample specific effect or interference, and different impacts are observed due to different measuring techniques and different evaluation of reaction curves.Samples without interferences, such as quality controls and fresh frozen plasma, recovered comparable on both systems.

• Brand Name: PATHROMTIN® SL
• Type of Device: PATHROMTIN® SL
• 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 PRODUCT 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 Key: 6890657
• MDR Text Key: 88215089
• Report Number: 9610806-2017-00104
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2018
• Device Model Number: PATHROMTIN® SL
• Device Catalogue Number: 10484200 (SEE SECTION H10)
• Device Lot Number: 536695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• 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 Number: 1
• Patient Age: 83 YR