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 2017-04-25 for PATHROMTIN SL 10446066 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[73639466]
A siemens healthcare diagnostics inc. (siemens) field service engineer (fse) was dispatched to the customer site to determine the cause of the discordant high activated partial thromboplastin time (aptt) result on the sysmex cs-5100 system and found no issues. The controls were in expected range. A non-numerical result (****) with the error code [no coagulation] had been released as a numerical result >170 seconds although the instruction for use provides the following instructions: "the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or a reagent problem. Repeat the analysis and make an overall judgement of the sample, reagents and the like. Also, set a longer detection time and repeat the analysis". Therefore, it has been concluded that a user error caused or contributed to the event. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73639467]
A discordant, falsely elevated activated partial thromboplastin time (aptt) result was reported on a patient sample on the sysmex cs-5100 instrument. The discordant high aptt result was provided to the physician. It is unknown whether the physician questioned the discordant result. The same patient sample was re-run the next day using two assays on the same sysmex cs-5100 instrument. The re-run result was reported to the physician. A new patient sample was also taken to confirm the re-run result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5
[76992654]
Siemens healthcare diagnostics inc. Filed the initial mdr (9610806-2017-00054) on april 25, 2017. Corrected report - april 28, 2017. Siemens healthcare diagnostic inc. Determined that the correct lot number for pathromtin sl is 536692b, expiration date april 7, 2018. The corresponding catalog number is 10446066. The udi number was updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2017-00054 |
| MDR Report Key | 6519964 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-25 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-04-28 |
| Date Added to Maude | 2017-04-25 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9146216083 |
| 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 | 2017-04-25 |
| Model Number | PATHROMTIN SL |
| Catalog Number | 10446066 |
| Lot Number | 536692B |
| Device Expiration Date | 2018-04-07 |
| 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 PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |