MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BC THROMBIN REAGENT

Model Number BC THROMBIN REAGENT

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) is investigating the cause of the variability in thrombin time (tt) results between different reagent and control lots.The bcs xp system reference guide states that "reference intervals vary from laboratory to laboratory depending on the population, the technique and reagent lot.Therefore, each laboratory must establish its own reference intervals or verify them whenever one or more of the aforementioned variables are changed." differences in seconds for normal patient results due to the dependency on the reagent lot used potentially contributed to the variability in tt results.Mdr 9610806-2017-00095 was filed for the same event.

Event Description

Elevated thrombin time (tt) patient sample results were obtained on the bcs xp system with bc thrombin lot 517468 (kit lot # 46751) and reported to the physician(s), who questioned the results.The customer indicated that the elevated tt results may potentially lead to a delay in planned patient treatment, but no patients were clinically impacted.The customer indicated the average tt results for normal patients increased with bc thrombin lot 517468 compared to bc thrombin lot 517467.The customer did not provide any patient data for evaluation.Although within range of the tables of assigned values, the customer observed an increase in the internal quality control (qc) for bc thrombin lot 517468 and bc thrombin lot 517469 compared to bc thrombin lot 517467, with the allowable total error (tea) sometimes exceeding the laboratory's specification of 10%.External quality controls (riqas and cobjwdl) were run between march and july of 2017 on bc thrombin lots 517468 and 517469 and recovered above the expected value(s).Based on the variability in quality control recovery, the lab stopped running the thrombin time tests on patient samples.There are no known reports of patient intervention or adverse health consequences due to the elevated tt results.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr on september 1, 2017.Additional information (september 20, 2017): upon further investigation, siemens determined that the customer did not update the system's quality control file with the new lots' (517468) table of assigned values (tav) ranges.Using the previous lots' tav ranges, the customer ran quality controls and potentially patient samples.The customer corrected the system's tav ranges and ran control normal, which recovered within expected ranges.The initial mdr indicated that external quality controls (riqas and cobjwdl) were run between march and july of 2017 on bc thrombin lots 517468 and 517469 and recovered above the expected value(s).Based on further investigation, siemens determined that the customer used the standard thrombin time (tt) assigned to the previous bc thrombin lot (517467) for external quality controls that were based on tt ratio.Based on the bc thrombin reagent's instruction for use, "in a study of 39 citrated plasma samples from healthy adults using bc thrombin reagent on the bct®, the calculated 95th percentile was determined to be < 21 seconds.Systematic deviations from this range may be due to the instrument used.If necessary, the laboratory may have to establish its own reference interval." the customer did not define a reference interval for the affected reagent lot.The cause of the event is user error.Additional information (october 5, 2017): siemens healthcare diagnostics has confirmed that the bc thrombin reagent kit lot 46751 (contains thrombin reagent lot 517468) and kit lot 47184 (contains thrombin reagent lot 517469) produce unexpected prolonged thrombin time (tt) results for expected normal samples, and may recover above the upper limit of normal (< 21 seconds) as stated within the ifu (instruction for use).The investigation by siemens confirmed that the reference range is shifted to an approximately 20% prolonged tt.If the reference range is not adjusted for the current affected lot, this may lead to a higher number of samples requiring follow-up in the case of slightly prolonged tt.There is a potential for misinterpreting unexpected prolonged results as unfractionated (uf) heparin contamination and some other thrombin inhibitors.An urgent field safety notice (ufsn) (b)(4) was sent to outside the us (ous) customers and an urgent medical device correction (umdc) (b)(4) was sent to us customers in october 2017.The ufsn and umdc remind customers that reference intervals vary from laboratory to laboratory depending on the population, the technique and reagent lot.Therefore, each laboratory must establish its own reference intervals or verify them whenever one or more of the aforementioned variables are changed.The ufsn and udmc also informs customers using the bc thrombin reagent as a screening assay for thrombin inhibition that the affected lots are more sensitive with approximately 20% prolonged/elevated tt results.This will lead to an increased rate of results above the reference range if not adjusted.Thus, the ufsn and udmc advise customers to adjust their specific reference ranges as per the application sheet for thrombin time with bc thrombin when changing to a new lot.

• Brand Name: BC THROMBIN REAGENT
• Type of Device: BC THROMBIN REAGENT
• 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 Key: 6839145
• MDR Text Key: 85369819
• Report Number: 9610806-2017-00094
• Device Sequence Number: 1
• Product Code: GJA
• UDI-Device Identifier: 00842768013102
• UDI-Public: 00842768013102
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K970645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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: 09/08/2018
• Device Model Number: BC THROMBIN REAGENT
• Device Catalogue Number: 10446636
• Device Lot Number: 46751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 10/18/2017
• 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
• Removal/Correction Number: 9610806-10/18/2017-003-C
• Patient Sequence Number: 1