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

Model Number	BC THROMBIN REAGENT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics investigated the event to determine the cause of the elevated thrombin time (tt) results on the bcs xp systems and determined that the customer was comparing two different methods for tt determination.The customer used the bc thrombin reagent on the bcs xp systems, while they used the test thrombin reagent on the sysmex ca-660 system to obtain tt results on patient samples.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) ph-17-018.A.Ous was sent to outside the us (ous) customers and an urgent medical device correction (umdc) ph17-018.A.Us 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.Mdr 9610806-2017-00124, mdr 9610806-2017-00125, mdr 9610806-2017-00126, and mdr 9610806-2017-00127 were filed for the same event.
Event or Problem Description
Elevated thrombin time (tt) results were obtained on multiple patient samples on two bcs xp systems using bc thrombin reagent lot 517468 (kit lot 46751).These results were not reported to the physician(s).The same samples were rerun on an alternate sysmex ca-660 system using an alternate test thrombin reagent, resulting lower for most samples.The result obtained on the sysmex ca-660 recovered higher for (b)(6).The results obtained on the sysmex ca-660 system were reported to the physician.Internal quality controls were within range on all systems at the time of event.There are no known reports of patient intervention or adverse health consequences due to the elevated tt results.

• Brand Name: BC THROMBIN REAGENT
• Common Device Name: BC THROMBIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg D-350 41; GM D-35041
• MDR Report Key: 6995317
• Report Number: 9610806-2017-00120
• Device Sequence Number: 1005750
• Product Code: GJA
• UDI-Device Identifier: 00842768013102
• UDI-Public: 00842768013102
• Combination Product (Y/N): N
• PMA/510(K) Number: K970645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9610806-10/18/2017-003-C
• Patient Sequence Number: 1