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 2017-08-11 for PATHROMTIN SL 10484200 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[82709032]
Siemens healthcare diagnostics personnel 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 a drifting baseline which was flagged according to the algorithm. Results with pathromtin sl are either "no clot" or prolonged and are an indication of a coagulation disorder. A difference between the results obtained on the bcs xp system and the cs-5100 system may be due to the differences in method application used and differences in the clot detection algorithms. The instrument and reagent are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2017-00089 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[82709033]
High activated partial thromboplastin time (aptt) results on one patient sample were generated on the sysmex cs-5100 analyzer (serial number (b)(4)) using the pathromtin sl assay (initial result and repeat results 1, 3, and 4) versus the actin fs assay (repeat result 2). The initial aptt result of >160sec was reported to the physician who did not question the result. The actin fs assay aptt repeat result 2 of 23. 7sec was also reported to the physician. It is unknown what the expected aptt result should have been for the patient. The same sample and system were used for tesing with both assays. All qc recovery was acceptable. 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 | 9610806-2017-00088 |
| MDR Report Key | 6789793 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-11 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2017-01-18 |
| Date Added to Maude | 2017-08-11 |
| 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 | 2017-08-11 |
| Catalog Number | 10484200 |
| Lot Number | 536695 |
| Device Expiration Date | 2018-07-24 |
| 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 | 2017-08-11 |