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 2018-10-02 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[122808550]
The customer contacted a siemens customer care center and reported that they obtained a discordant, falsely low unfractionated (uf) heparin result on a patient sample on the bcs xp system, using a non-siemens reagent. The customer reported that quality controls (qcs) were within expected ranges on the day of the event and that the issue is isolated to one patient sample. A siemens customer service engineer (cse) was dispatched to the customer's site and the cse determined that there was no indication of an instrument malfunction when the discordant result was obtained on the patient sample. There were neither error codes nor error conditions, on the affected bcs xp system, that were related to this issue at the time of the event. During this visit, the cse: cleaned the optics read window; adjusted the reference channel; verified all optics settings and values; repeated the affected sample; ran qcs. The qcs recovered acceptably and the results obtained on the affected sample were repeatedly <0. 00 iu/ml. The cse replaced the flash lamp and repeated the sample; the same result (<0. 00 iu/ml) was obtained on the patient sample. Then, the cse reinstalled the previous flash lamp and the customer recalibrated the heparin assay. The affected sample was repeated after the customer recalibrated the assay, resulting in the same result. The use of the non-siemens' reagent on the siemens' bcs xp system is a user defined method and not validated by siemens. The cause of the discordant, falsely low uf heparin result is unknown. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[122808551]
A discordant, falsely low unfractionated (uf) heparin result was obtained on a patient sample on a bcs xp system, using a non-siemens reagent. The discordant result was reported to the physician(s). The sample was repeated on an alternate bcs xp system using the non-siemens reagent, resulting higher. The repeat result was reported, as the correct result, to the physician(s). The sample was also repeated on (b)(6) 2018 on the alternate bcs xp system and on (b)(6) 2018 on the initial bcs xp system for troubleshooting purposes; the results obtained on the sample on the initial system were 0. 00 iu/ml. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low uf heparin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00101 |
| MDR Report Key | 7926547 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| 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 | 2018-10-02 |