MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-18 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[3135982]
A discrepant elevated activated partial thromboplastin time (aptt) clotting time result was reported on a patient sample. The same sample was repeated and a lower result was obtained. The patient was treated on the basis of the elevated aptt result. The patient was administered fresh frozen plasma and cryoprecipitates. There is no report of adverse outcome to the patient as a result of the discrepant elevated aptt result and treatment.
Patient Sequence No: 1, Text Type: D, B5
[10572716]
The cause of discrepant elevated activated partial thromboplastin time (aptt) results is unknown. A contributor to at least one of the elevated results was user error. One sample was draw from a line with heparin in the line. The pattern of discrepant results is strongly suggestive of patient sample specific factors. The instrument and software is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00004 |
| MDR Report Key | 2966262 |
| Report Source | 05,06 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-01-25 |
| Date of Event | 2013-01-24 |
| Date Mfgr Received | 2013-01-25 |
| Device Manufacturer Date | 2012-04-05 |
| Date Added to Maude | 2013-04-30 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 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 | 2013-02-18 |
| Catalog Number | B4219 |
| Lot Number | 547339 |
| Device Expiration Date | 2014-03-19 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |