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 2019-03-08 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[140625475]
The customer contacted a siemens customer care center (ccc); the customer asked which international sensitivity index (isi) value should be used on a laboratory information system (lis) when calculating international normalized ratio (inr) results. The customer reported that since (b)(6) 2019, they reported patient results using the incorrect isi result and indicated that they will gather patient results that were tested in that time period. On (b)(6) 2019, the customer provided the results in mdr 9610806-2019-00015. The cause of the event was a use error. There was no instrument malfunction. The customer is aware of the instrument's labelling. The customer corrected the isi value on the lis. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[140625476]
The customer reported that they used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results for multiple patient samples on a bcs xp system. The customer used the isi value of 0. 93 to calculate patient samples inr results instead of the isi value of 1. 09. The customer indicated that since (b)(6) 2019, they reported patients' inr results using the incorrect isi value for 3 weeks; as per the customer 26 patients (44 samples) were impacted by this issue. However, the customer did not identify which patients were impacted. The correct inr results were reported to the physician(s). There was no report of patient intervention or adverse health consequences due to the customer using the incorrect international sensitivity index (isi) value to calculate inr results for patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00015 |
| MDR Report Key | 8406029 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-08 |
| 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 | MR. BENLEY SAINT-JEAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242398 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER: 300360107 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 | 2019-03-08 |
| 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 | 2019-03-08 |