MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL S

Model Number	THROMBOREL S
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the site and made slight mechanical adjustments to the sample and reagent probe positions and performed probe cleaning even though there was no evidence of contamination.The temperature of the probe, detector and cooler were verified and within specifications.Quality controls (qc) were run and recovered within specifications, and a prothrombin time (pt) precision run was performed which successfully passed.No system abnormalities were observed.Siemens headquarters further investigated the issue.Qc recovered in range at the time of the event for both sysmex ca-660 systems.The customer stored the samples at 2 to 8 °c for three days before retesting the samples.As per the instructions for use (ifu) for thromborel s regarding sample collection and preparation, "store in an unopened tube at room temperature.Do not store on ice or at 2 to 8 °c as cold activation of f vii may alter results." therefore the higher inr recoveries between the 15th and 18th april results are potentially related to the wrong storage conditions.A sample mix up or a pre-activation or blood drawing issue (such as not mixing correctly with the anticoagulant) cannot be ruled out as a cause of the initial falsely low inr results.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a sysmex ca-660 system (serial number: (b)(4)) using thromborel s reagent.The discordant result was reported to the physician(s) and was questioned.The following day, a new sample from the same patient was run for inr at an alternate lab, recovering higher.This result was reported, as the correct result, to the physician(s).Two days later, the initial sample from the patient was repeated for inr on the customer's alternate sysmex ca-660 system (serial number: (b)(4)) using thromborel s reagent, also recovering higher.This triggered a lookback and it was found that discordant, falsely low inr results were obtained on three additional patient samples that were run three days prior on the lab's sysmex ca-660 system (serial number: (b)(4)) using thromborel s reagent.The same three patient samples were repeated for inr on sysmex ca-660 system (serial number: (b)(4)) using thromborel s reagent, all recovering higher.All of the repeat inr results were considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low prothrombin time international normalized ratio (inr) results.

• Brand Name: THROMBOREL S
• Common Device Name: THROMBOREL S
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10065361
• Report Number: 9610806-2020-00022
• Device Sequence Number: 3775796
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 565677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1