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

Model Number THROMBOREL S

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, precision testing was performed on the prothrombin time (pt) test and the fibrinogen test on the sysmex cs-2100i system using a pathological patient sample and precision testing was also performed on quality controls (biorad qc (level 3)).The results of the precision tests recovered within specifications.Quality controls (qcs) (biorad qc level 1, biorad qc level 2 and biorad qc level 3) were run on the system and precise results, within expected ranges, were obtained.The lab indicated that they will run pt patient samples, in duplicate, until they are confident with the results.A siemens healthcare diagnostics (siemens) field service engineer (fse) was dispatched to the customer site to determine the cause of the discordant, falsely elevated pt and pt international normalized ratio (inr) results on the sysmex cs-2100i system.Siemens verified that the qcs recovered within expected ranges at the time of the event and collected data for further investigation.A siemens headquarters support center (hsc) specialist further analyzed the backup files provided by the customer and determined that no user defined methods (udm) were used on the system.The original siemens pt thromborel s settings were used at the time of the event.The hsc specialist determined the qcs recovered within expected ranges on both days ((b)(6) 2017) and that all the sample measurements were correctly evaluated.The cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this reagent or system is required.

Event Description

On (b)(6) 2017, discordant, falsely elevated prothrombin time (pt) results and discordant, falsely elevated pt international normalized ratio (inr) results were obtained on 2 patient samples on the sysmex cs-2100i system.Sample (b)(6) was automatically rerun by the system and rerun by the user, resulting lower than the initial results.None of the results obtained on (b)(6) 2017 for (b)(6) were reported to the physician, while the discordant pt inr result was reported for (b)(6).The physician did not question the discordant result.(b)(6) was also rerun on an alternate non-siemens (roche) system, resulting lower than the initial result.On the following day, a new sample was collected from the patient of (b)(6) and run on the same sysmex cs-2100i system, resulting lower than the initial results.(b)(6) was rerun on the same system, resulting lower than the initial results.The results obtained on both samples on (b)(6)2017 were considered to be correct and reported to the physician(s).The pt test was ordered by the physician(s) to monitor the patients' warfarin therapy.The expected results for these patients were unknown since the patients' warfarin therapy dosage was not provided by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt and pt inr results.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00149 on 18-dec-2017.Additional information (18-dec-2017): on 18-dec-2017, siemens field service engineer (fse) was dispatched to the customer's site to determine the cause of the discordant, falsely elevated prothrombin time (pt) results and discordant, falsely elevated pt international normalized ratio (inr) results on the sysmex cs-2100i system.The fse observed a drip on the reagent probe and determined that the drip was coming from an air valve.Due to this, the fse replaced the air valve, performed several probe rinses and primes, and verified that no drips were found.Then, the fse ran quality controls (qcs) and the qc recovered within specifications.Precision testing was performed again on the sysmex cs-2100i system and the results improved from the previous precision tests.The lab resumed testing patient samples in single mode.There is no indication that a reagent issue contributed to the discordant results.Section has been updated to reflect this information.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00149 on 18-dec-2017.Siemens filed the first supplemental mdr 9610806-2017-00149_s1 on 08-jan-2018.Additional information (08-jan-2018): on 08-jan-2018, siemens received sysmex investigation for this event.Sysmex is the legal manufacturer of the sysmex cs-2100i system and sysmex determined that coagulation patient samples should not be stored in the fridge, since low temperatures might activate coagulation factors.A pre-analytical issue potentially contributed to the discordant results.Based on the thromborel s instruction for use (ifu), samples should not be stored on ice or in temperatures at 2 to 8 degrees celsius as cold activation of factor vii may alter results.Sample (b)(6) was refrigerated at 4 degrees celsius between the initial and repeat testing.This potentially contributed to the difference in prothrombin time (pt) results obtained for this patient.Additional information (17-jan-2018): on 17-jan-2018, sysmex indicated to siemens that sysmex investigated the reagent log and coagulation waveforms on the sysmex cs-2100i system and determined that both initial tests were measured using the same reagent vial.Both initial tests were run using reagent that was near the bottom of the vial.The repeat tests were performed using a different reagent vial.Compared to the repeat tests, the turbidity of the initial tests was higher.Aspiration of the high turbid reagent used to obtain the initial results was the cause of the event.

• Brand Name: THROMBOREL S
• Type of Device: 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: 7127399
• MDR Text Key: 96007519
• Report Number: 9610806-2017-00149
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (y/n): N
• PMA/PMN Number: K003870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

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: 01/26/2019
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 546998
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 12/18/2017; 01/08/2018
• Supplement Dates FDA Received: 01/08/2018; 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1