MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-01 for BC THROMBIN REAGENT manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[84428171]
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. The bc thrombin reagent lot number is provided as the bc thrombin kit lot number, catalog number, di and expiration date were not available at the time of filing. Mdr 9610806-2017-00094 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[84428172]
The customer ran patient samples using bc thrombin lot 517467 on the bcs xp system when the allowable total error (tea) for internal quality controls exceeded the laboratory's specification of 10%. The internal quality controls were within the range of the tables of assigned values (tav). The customer indicated the average thrombin time results for normal patients obtained with lot 517467 were low compared to lot 517468. The customer did not provide any patient data for evaluation. There are no known reports of patient intervention or adverse health consequences due to the tt results obtained on patient samples when the tea for internal quality controls exceeded the laboratory's specifications of 10%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00095 |
| MDR Report Key | 6839175 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2017-10-05 |
| 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 | 3 |
| Brand Name | BC THROMBIN REAGENT |
| Generic Name | BC THROMBIN REAGENT |
| Product Code | GJA |
| Date Received | 2017-09-01 |
| Model Number | BC THROMBIN REAGENT |
| Lot Number | 517467 |
| 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 |