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 2016-05-12 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219-2 SMN 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[45100024]
The cause of the reported incident, the administration of an extra dose of heparin is the discrepancy between therapeutic range values for heparinized patients between two facilities. There is no indication of erroneous results reporting by the complainant facility, (b)(6). This first facility follows the general recommendations for performing heparin therapeutic range testing with every change between old and new lots of aptt reagents and tracking the cumulative difference between lots. Siemens healthcare has provided the second facility, (b)(6), with the 2014 siemens white-paper on therapeutic heparin testing to evaluate their current practices. The actin fsl aptt reagent is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[45100365]
A change in treatment which occurred due to differences in activated partial thromboplastin time (aptt) heparin therapeutic ranges between two hospital facilities. A patient with an aptt result within the therapeutic range at the first facility was transferred to a second hospital facility. A medic involved in the transfer regarded the aptt result as low relative to the heparin therapeutic range at the second hospital facility. The patient was administered an extra dose of heparin based on the difference in therapeutic ranges. There is no indication that patient treatment was altered or prescribed on the basis of the difference in therapeutic ranges or the additional heparin dose administered. There was no report of adverse health consequences as a result of the difference in therapeutic ranges or the additional heparin dose administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00018 |
| MDR Report Key | 5651770 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-04-14 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2016-05-12 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2016-05-12 |
| Catalog Number | B4219-2 SMN 10445714 |
| Lot Number | 547468A |
| Device Expiration Date | 2017-05-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-12 |