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 2018-05-22 for BCS XP 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[109371808]
Siemens healthcare diagnostics has determined that the cause of the discordant high prothrombin time (pt)/ international normalized ratio (inr) patient a siemens customer service engineer (cse) was dispatched to the customer site. The cse analyzed the instrument and determined that the cause of the discordant high prothrombin time (pt)/ international normalized ratio (inr) patient sample results on one patient was due to defective tygon tubing that malfunctioned. The cse replaced the tygon tubing and the sample probe on the bcs xp analyzer (serial number (b)(4)). The system was returned to operation. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[109371809]
Discordant high prothrombin time (pt)/ international normalized ratio (inr) patient sample results on one patient were generated using dade innovin lot 549706 on a bcs xp analyzer (serial number (b)(4)). The discordant, high pt/inr results were not reported to the physician. The same patient sample was repeated on the bcs xp analyzer (s/n (b)(4)) and lower pt/inr results were generated which matched clinical history. These pt/inr results were reported to the physician. All quality control was in range prior to testing. There are no reports of patient intervention or adverse health consequences due to the discordant, high pt/inr patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00050 |
| MDR Report Key | 7534942 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-01-30 |
| Date Added to Maude | 2018-05-22 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | 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 |
| Generic Name | BCS XP |
| Product Code | GKP |
| Date Received | 2018-05-22 |
| 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 STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |