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

Model Number BC THROMBIN REAGENT

Device Problem High Test Results (2457)

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

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

A customer performed a normal reference range verification study using donor samples for both bc thrombin reagent lots (517469 (kit lot# 47184) and 517467 (kit lot # 46348)) and verified their current normal reference range of 0-20.9 seconds.When the customer repeated the validation study with 20 local donors using lot 517469, they observed that some results exceeded the upper limit of their normal reference range.The customer also ran a comparison study between the two bc thrombin reagent lots and observed higher qc recovery and patient results using lot 517469.The results from the correlation study for lot 517469 did not meet the lab's acceptance criteria.However, the customer indicated that the positive bias observed with lot 517469 does not impact the qualitative values for patients and they approved the use of lot 517469.Based on the positive bias, the customer adjusted the upper limit of their normal reference range from 20.9 seconds to 23 seconds.They expressed a concern regarding increase usage of hepzyme on patient samples as they use hepzyme on all results exceeding 30 seconds.The customer started using the new lot on (b)(6) 2017.There are no known reports of patient intervention or adverse health consequences due to the high thrombin time recovery on patient samples and qc.

• 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: 6995849
• MDR Text Key: 92048417
• Report Number: 9610806-2017-00130
• Device Sequence Number: 1
• Product Code: GJA
• UDI-Device Identifier: 00842768013102
• UDI-Public: 00842768013102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/02/2017

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: 02/21/2019
• Device Model Number: BC THROMBIN REAGENT
• Device Catalogue Number: 10446636
• Device Lot Number: 47184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/02/2017
• 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