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 2019-03-25 for BCS XP SYSTEM 10461894 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[139743074]
The customer contacted a siemens customer care center. A siemens customer service engineer (cse) was dispatched to the customer's site. During this visit, the customer service engineer noticed the optics were out of range, and replaced the xenon lamp. Siemens determined that the error-log analysis showed that level errors were triggered at the time of the event for both pipettors. Siemens further investigated the issue and discovered that the control measurement after bottle change setting was not activated by the customer within the reagent definition on this instrument. Siemens determined that the customer did not run quality controls (qc) after replacing the dade innovin reagent vial prior to running patient samples. The next dade innovin reagent vial loaded by the customer was checked with qc, and the qc were within acceptable ranges. The cause of the discordant results was due to a use error, as the customer did not run qc prior to running patient samples, as recommended in the dade innovin reagent instructions for use. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[139743075]
Discordant, falsely low prothrombin time percent (pt%) results and discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on multiple patient samples on a bcs xp system using the dade innovin reagent. The discordant results were reported to the physician(s), and the results were questioned by the physician(s). The samples were repeated on the same system after the customer loaded a new bottle of reagent, resulting in higher pt% and lower inr results. The repeat results were reported, as the correct results, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant pt% and pt inr results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00038 |
| MDR Report Key | 8448936 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| Manufacturer City | SCHWALBACH, |
| Manufacturer Country | GM |
| 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 | 2019-03-25 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10461894 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |