MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for BC THROMBIN REAGENT 10446636 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[85369819]
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.
Patient Sequence No: 1, Text Type: N, H10
[85369820]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00094 |
| MDR Report Key | 6839145 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-09-01 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-10/18/2017-003-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BC THROMBIN REAGENT |
| Generic Name | BC THROMBIN REAGENT |
| Product Code | GJA |
| Date Received | 2017-09-01 |
| Model Number | BC THROMBIN REAGENT |
| Catalog Number | 10446636 |
| Lot Number | 46751 |
| Device Expiration Date | 2018-09-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-09-01 |