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 2017-09-25 for PATHROMTIN? SL 10484200 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[88215089]
Siemens healthcare diagnostics inc. (siemens) analyzed the backup data provided by the customer to determine the cause for the differences in aptt results on the affected patient sample. Siemens found no issues with the reaction kinetics on the bcs xp system and determined that the bcs xp system performed as expected. Siemens is investigating the cause of the discordant, falsely elevated results obtained on the sysmex cs-5100 systems. The pathromtin? Sl reagent with catalog number 10484200 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific reagents. The pathromtin? Sl reagents marketed in the us have catalog numbers 10446066 and 10446067.
Patient Sequence No: 1, Text Type: N, H10
[88215090]
Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on a patient sample on two different sysmex cs-5100 systems. The discordant aptt results were not reported to the physician. The same patient sample was rerun using an alternate pathromtin sl lot on a bcs xp system, recovering lower. The customer reported the result obtained on the bcs xp system. The physician expected an aptt result in the normal range. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00104 |
| MDR Report Key | 6890657 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-25 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-09-25 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 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 | 2017-09-25 |
| Model Number | PATHROMTIN? SL |
| Catalog Number | 10484200 (SEE SECTION H10) |
| 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- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-25 |