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 2020-01-27 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[177022654]
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low heparin result was obtained on a patient sample on a bcs xp system. A siemens customer service engineer (cse) was dispatched to the site. The cse replaced the sample probe, the syringes, and the dilutor. The issue was isolated to one sample and no instrument errors occurred at the time of the event. Quality controls recovered within range at the time of the event. Possible causes of the event include a bubble in the system or the sample or improper mixing of the anticoagulant and the sample in the tube. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[177022655]
A discordant, falsely low heparin result was obtained on a patient sample on a bcs xp system. The discordant result was reported to the physician(s). The patient was admitted to the hospital based on the reported result and was administered low molecular weight heparin (lovenox). The next day the physician questioned the result and requested that the sample be repeated for heparin. The original sample was repeated twice for heparin, resulting higher. These results were reported, as the correct results, to the physician(s). There are no reports of adverse health consequences due to the patient being administered lovenox as a result of the discordant, falsely low heparin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2020-00002 |
| MDR Report Key | 9632274 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-27 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-01-27 |
| 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 | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| 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 | 2020-01-27 |
| 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 | 2020-01-27 |