MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-02 for BC THROMBIN REAGENT 10446636 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[92048417]
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.
Patient Sequence No: 1, Text Type: N, H10
[92048418]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00130 |
| MDR Report Key | 6995849 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-11-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-10/18/2017-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BC THROMBIN REAGENT |
| Generic Name | BC THROMBIN REAGENT |
| Product Code | GJA |
| Date Received | 2017-11-02 |
| Model Number | BC THROMBIN REAGENT |
| Catalog Number | 10446636 |
| Lot Number | 47184 |
| Device Expiration Date | 2019-02-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |