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 2019-01-10 for BCS XP SYSTEM 10461894 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[134193025]
The customer contacted a siemens customer care center and reported that discordant, falsely low fibrinogen results were obtained on two samples from the same patient on a bcs xp system using the fib low 570 assay protocol; additionally, the customer provided the imprecise prothrombin time (pt), pt % and pt international normalized ratio (inr) results obtained on the samples. The customer reported that the issue is observed on two bcs xp systems at the laboratory, but did not provide the data to support their report. The fib570 assay protocol is used as a backup for icteric, hemolyzed or lipemic samples that could not be processed with the fib assay protocol. The fib low assay protocol is used for samples with expected fibrinogen concentration below the normal range that cannot be processed with fib assay protocol. Siemens is investigating the issue. Mdr 9610806-2019-00004 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) and mdr 9610806-2019-00005 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) from the same patient.
Patient Sequence No: 1, Text Type: N, H10
[134193028]
A discordant, falsely low fibrinogen (fib) result was obtained on a patient sample on a bcs xp system, using the fib low570 assay protocol. The discordant result was not reported to the physician(s). The sample was previously tested for fib on the same system using the fib and fib570 assay protocols, and compared to the discordant result, higher results were obtained using the fib and fib570 assay protocols. The result obtained using the fib570 assay protocol was considered to be correct and was reported to the physician(s). Additionally, imprecise prothrombin time (pt), pt %, and pt international normalized ratio (inr) results were obtained on the sample using the dade innovin reagent and same system. The correct pt %, pt and pt inr results for this patient are unknown and it is unknown if any of the pt %, pt and pt inr results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low fibrinogen result and imprecise pt %, pt and pt inr results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00004 |
| MDR Report Key | 8233521 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-11-10 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-01-10 |
| 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 | 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 | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| 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 | 2019-01-10 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10461894 |
| 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 | 2019-01-10 |