MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-28 for TEST THROMBIN REAGENT OWHM manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[5705786]
A customer running a lab for remote samples was contacted by one of his clients that a surgery had been postponed based on a potentially falsely prolonged thrombin time (tt) result. The patient result was reported to the physician. It is unknown if patient treatment was otherwise altered or prescribed on the basis of the potentially falsely prolonged thrombin time (tt) result. There is no report of adverse outcome to the patients as a result of the potentially falsely prolonged thrombin time (tt) result.
Patient Sequence No: 1, Text Type: D, B5
[13228737]
The cause of the discrepant potentially falsely prolonged thrombin time (tt) result is unknown. The affected sample material was not available for internal investigation. However, investigation with other samples is ongoing to assess a potential for prolonged tt results in sec. Based on qc and the device function with other assays and parameters, there is no indication for a potential performance issue with the sysmex ca-7000 instrument. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2015-00009 |
| MDR Report Key | 4732547 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-28 |
| Date of Report | 2015-03-30 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2014-07-18 |
| Date Added to Maude | 2015-05-29 |
| 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 | TEST THROMBIN REAGENT |
| Generic Name | TEST THROMBIN REAGENT |
| Product Code | GJA |
| Date Received | 2015-04-28 |
| Catalog Number | OWHM |
| Lot Number | 44083 |
| Device Expiration Date | 2016-06-12 |
| 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 | 2015-04-28 |