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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BC THROMBIN REAGENT Back to Search Results
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.
 
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Brand NameBC THROMBIN REAGENT
Type of DeviceBC 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 Key6995849
MDR Text Key92048417
Report Number9610806-2017-00130
Device Sequence Number1
Product Code GJA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2019
Device Model NumberBC THROMBIN REAGENT
Device Catalogue Number10446636
Device Lot Number47184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2017
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 Number9610806-10/18/2017-003-C

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