MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-25 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[109752760]
The customer contacted siemens customer care center and reported that on (b)(6) 2018, a siemens customer service engineer (cse) moved the barbicide and rinse water bottles, used for the bcs xp system, further away from the system. The customer reported that multiple discordant, falsely elevated pt inr results were obtained on the system due to the new location of these bottles. Prior to this event, a cse was dispatched to the customer's site due to an overflowing barbicide issue on the system; siemens determined that the customer performed proper reconstitution of barbicide. The cse checked the tubing from and to the bottles and verified that they were properly connected. The cse also emptied the barbicide tubing and performed multiple liquid dispense corrections, including washing the probes, filling syringes, and determined that no fluids came back into the tube. The customer monitored the barbicide container for three weeks and determined that there was no recurrence of the issue. On 25-apr-2018, a cse was dispatched to the customer's site to determine the cause of the discordant, falsely elevated pt inr results and found no issue. After the cse's visit, the customer moved the barbicide and water bottles to their original locations and reported that no further discordant results or quality control issues were observed. The cause of the discordant, falsely elevated pt inr results is unknown. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[109752761]
Discordant, falsely elevated prothrombin time (pt) international normalized ratio (inr) results were obtained on multiple patient samples on the bcs xp system, using the dade innovin reagent. The discordant results were reported to the physician(s), who questioned the results. Due to the discordant pt inr results, the administration of warfarin medication for patients of sample ids (sids) ci, dp, and ev was delayed, the patient of sid pf was treated with a lower dosage of warfarin medication, and the patient of sid jp was unnecessary administered vitamin k. The same samples were rerun on the same system, resulting lower. The repeat results were reported, as the correct results, to the physician(s). The customer reported that twenty additional patients were rerun on (b)(6) 2018, but did not provide the data for these patients. There are no known reports of adverse health consequences due to the discordant, falsely elevated pt inr results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00049 |
| MDR Report Key | 7545435 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-25 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-05-25 |
| 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 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3 |
| 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 | 2018-05-25 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10459330 |
| 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 | 2018-05-25 |