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 2019-03-19 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[139237738]
The customer contacted a siemens customer care center (ccc). The customer reported that they calculated the affected patients' prothrombin time (pt) international normalized ratio (inr) results with the international sensitivity index (isi) value in the table of assigned values (tav); this is acceptable when the pt inr calculation is intended to be performed on the bcs xp system. However, the customer calculated the pt inr results on a non-siemens laboratory information system (lis); as per a siemens communication to customers in december of 2012, when customers rollover to a dade innovin reagent lot, customers are instructed to contact the siemens technical solutions center to obtain the correct isi to be updated in the lis. The customer indicated that they are aware of this communication, contacted siemens, and siemens provided a letter to the customer (dated 15-jan-2019) with the correct isi value to use for their dade innovin reagent lot (549722). As per siemens instructions, the customer updated the isi result in their lis. Siemens further investigated the issue and determined that there was no instrument or reagent malfunction; the bcs xp system evaluated the results correctly and the results were correctly transmitted to the lis. A use error contributed to the incorrect pt inr results. The system is performing according to specifications. No further evaluation of this device is required. Mdrs 9610806-2019-00015_s1, 9610806-2019-00016, 9610806-2019-00017, 9610806-2019-00018, 9610806-2019-00019, 9610806-2019-00021, 9610806-2019-00022, 9610806-2019-00023, 9610806-2019-00024, 9610806-2019-00025, 9610806-2019-00026, 9610806-2019-00027, 9610806-2019-00028, 9610806-2019-00029, 9610806-2019-00030, 9610806-2019-00031, 9610806-2019-00032, 9610806-2019-00033, 9610806-2019-00034, 9610806-2019-00035, and 9610806-2019-00036 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[139237739]
The customer reported that they've used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results after the samples were processed correctly 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 daily for 3 weeks. As per the customer, 26 patients (41 samples) were impacted by this issue. The customer did not identify which patients were impacted nor the dates of testing. The patient's inr results were recalculated using the correct isi value. 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 | 9610806-2019-00020 |
| MDR Report Key | 8433111 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-19 |
| 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: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 | 2019-03-19 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10459330 |
| 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 D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |