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 2018-10-26 for PATHROMTIN SL 10446066 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[126533945]
The customer contacted siemens customer care center (ccc) to report that discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system. Siemens reviewed the instrument backup files and determined that quality controls (qcs) were within the expected specifications. Siemens identified that maintenance was performed regularly on the system and all inspected kinetics were evaluated correctly by the system software. The cause of the discordant, falsely elevated aptt result is patient's possible medical condition. The instrument is performing according to specifications. No further evaluation of the device is required. Mdr 9610806-2018-00108 was filed for the same event which occurred on (b)(6) 2018. Mdr 9610806-2018-00109 was filed for the same event which occurred on (b)(6) 2018. Mdr 9610806-2018-00110 was filed for the same event which occurred on (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[126533946]
Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system. The initial discordant result was reported to the physician(s), who questioned the result. Multiple samples from one patient were repeated on the same system, resulting falsely high. The patient was re-drawn and the new sample was run on a non-siemens instrument, resulting lower. The result obtained using the non-siemens methodology was reported, as the correct result to the physician(s). The patient's scheduled arthroscopic surgery was delayed due to the pathological, falsely elevated aptt results and further testing was required. The patient tested negative for factor and lupus anti-coagulants. 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
| Report Number | 9610806-2018-00111 |
| MDR Report Key | 8009187 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-10-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-26 |
| Model Number | PATHROMTIN SL |
| Catalog Number | 10446066 |
| Lot Number | 536696A |
| Device Expiration Date | 2018-09-25 |
| 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 | 2018-10-26 |