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 2017-03-24 for PATHROMTIN SL OQGS295 SMN 10446066 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[70787835]
The cause of the discordant elevated aptt result is unknown. The issue affected the individual sample. Siemens headquarters support center evaluated the information provided. There were no instrument malfunctions identified. The laboratory quality control values were within laboratory ranges. The issue was resolved with repeat testing of the same samples by an alternate siemens methodology. The postponed surgery was performed after evaluation of all testing results. The "pathromtin" sl intended use summary and explanation states: "the use of the aptt as a screening test for coagulation disorders is indicated particularly prior to surgical interventions as this allows potential hemophiliacs to be diagnosed and given special therapeutic protection. The presence of non-specific inhibitors such as the lupus-like anticoagulant may prolong the aptt, but this effect is variable and generally recognized as being related more to the nature of the aptt reagent employed. " the device is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[70787836]
A discordant elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on multiple sysmex instrument systems with the "pathromtin" sl reagent. The result was reported to the physician who questioned the result. The same sample was repeated on the same systems with an alternate siemens aptt reagent, actin fs, and a lower result was obtained and reported. The test was a preoperative screening and the surgery was temporarily postponed. There is no indication that patient treatment was otherwise altered or prescribed on the basis of the discordant elevated aptt result. There was no report of adverse health consequences as a result of the discordant elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00043 |
| MDR Report Key | 6431885 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-26 |
| Device Manufacturer Date | 2016-05-20 |
| Date Added to Maude | 2017-03-24 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE 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 | PATHROMTIN SL |
| Generic Name | PATHROMTIN SL |
| Product Code | GFO |
| Date Received | 2017-03-24 |
| Catalog Number | OQGS295 SMN 10446066 |
| Lot Number | 536689 |
| Device Expiration Date | 2018-01-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |