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 2017-09-29 for PATHROMTIN SL 10446067 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[89422537]
Siemens healthcare diagnostics reviewed the backup files provided by the customer of the sysmex cs-5100 analyzer to determine the cause of the high activated partial prothrombin time (aptt) result. Review of the sysmex cs-5100 analyzer backup file included analysis of the cs-5100 kinetics, which showed no issues and no error codes were triggered. The system operated as specified and a non-conformance could not be identified. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[89422538]
A discordant, high activated partial thromboplastin time (aptt) result of 115 seconds on one patient sample was generated on the sysmex cs-5100 analyzer using the pathromtin sl assay (lot 536693). This result was not reported to the physician. The same sample, using a different lot of pathromtin sl reagent (lot 536695), was tested on a bcs xp system generating an aptt result of 35. 5 seconds. This result was in line with the clinical picture of the patient. There are no reports of patient intervention or adverse health consequence due to the high aptt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00105 |
| MDR Report Key | 6904643 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-29 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2016-10-06 |
| Date Added to Maude | 2017-09-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| 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 | PATHROMTIN SL |
| Generic Name | PATHROMTIN SL |
| Product Code | GFO |
| Date Received | 2017-09-29 |
| Catalog Number | 10446067 |
| Lot Number | 536693A |
| Device Expiration Date | 2018-05-08 |
| 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 STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-29 |