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 2018-06-15 for BCS XP SYSTEM 10461894 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[111489988]
The customer contacted siemens customer care center (ccc) and reported that discordant "no clot" results were obtained on multiple patient samples, without further flags. A siemens field service engineer (fse) was dispatched to the customer's site. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[111489989]
The customer reported that discordant activated partial thromboplastin time (aptt) results of "no clot" were obtained on multiple patient samples on the bcs xp system when the pathromtin sl reagent vial was empty. The discordant results were not reported to the physician(s). The samples were rerun on an alternate bcs xp system or on the same bcs xp system after replacing the reagent vial, resulting in correct aptt results. The correct aptt results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant "no clot" aptt results obtained on patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00052 |
| MDR Report Key | 7607975 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-05-28 |
| Date Added to Maude | 2018-06-15 |
| 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 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| Manufacturer City | SCHWALBACH, 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BCS XP SYSTEM |
| Generic Name | BCS XP SYSTEM |
| Product Code | GKP |
| Date Received | 2018-06-15 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10461894 |
| 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 | 2018-06-15 |