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 2018-08-21 for BCS XP SYSTEM 11240019 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[118099139]
The customer contacted a siemens customer care center and reported that discordant results were obtained on an icteric sample on the bcs xp systems. Siemens reviewed the system files for the bcs xp system with serial (b)(4) and determined that the bcs xp system with sn (b)(4) performed as intended; siemens determined that the sample had an absorbance that exceeded the photometer capability on the bcs xp system. The patient sample also contained a bilirubin value of >30 mg/dl, which exceeded the bilirubin interference limitation of 12 mg/dl listed in the bcs xp system reference guide for multifibren u; the other coagulation test results also indicated that the sample was highly turbid. The cause of the discordant, falsely elevated fibrinogen results and imprecise pt % and pt inr results was potentially due to a sample specific issue. The systems are performing according to specifications. No further evaluation of these devices is required. Mdr 9610806-2018-00083 was filed for the different results obtained on the bcs xp system with sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118099140]
The customer reported that a flagged fibrinogen result was obtained on a patient sample on the bcs xp system with serial (b)(4) and was not transferred to the host. Due to this, the sample was repeated on the same system, resulting in a discordant, falsely elevated fibrinogen result. The discordant result was not reported to the physician(s). The same sample was repeated using the fibrinogen 570 and fibrinogen low 570 assays, resulting in a non-numerical result and an expected result for the patient. The sample was repeated for fibrinogen, fibrinogen 570 and fibrinogen low 570 on the bcs xp system with sn (b)(4), resulting in an elevated result, a non-numerical result and an expected result. The customer stated that the expected range for fibrinogen for this patient was between 50 and 100 mg/dl and did not indicate which results were reported to the physician(s). Additionally, imprecise prothrombin time (pt) % and pt international normalized ratio (inr) results were also obtained on the patient sample on the bcs xp system with sn (b)(4). The sample was also repeated on the bcs xp system with sn (b)(4) for pt % and pt inr, resulting lower for pt % and higher for pt inr than most pt results obtained on the bcs xp system with sn (b)(4). It is unknown whether any of the pt % or pt inr results was reported to the physician(s) and the correct results are unknown. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated fibrinogen result and imprecise pt % and pt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00082 |
| MDR Report Key | 7802835 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-21 |
| 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 | 2018-08-21 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 11240019 |
| 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 | 2018-08-21 |