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 2018-08-14 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[117436146]
The customer contacted a siemens customer care center and reported that on the day of the event, quality controls (qcs) recovered out of range on the bcs xp system; the customer ran the affected sample 3 hours after qcs recovered within expected ranges. The customer performed maintenance on the instrument on the day of the event and ran frozen samples on both systems for comparison purposes; the customer indicated that the results obtained from the comparison study matched the results initially reported to the physician(s) for these samples. The customer also determined that the calibration curves on systems were comparable. As per a siemens customer service engineer (cse)'s instructions, the customer washed the system's probes, changed the wash solution onboard, and ran a validation kit, resulting acceptably. A siemens cse was dispatched to the customer's site twice; during these visits, the cse recalibrated the cooler temperature and replaced the sample probe, sample wash pump, disinfectant and rinse valve and temperature thermistor in the rack. The cse also calibrated the temperature thermistor, aligned the probe, and ran qcs and a validation kit, resulting acceptably. The cause of the discordant, falsely low heparin lmw 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
[117436147]
A discordant, falsely low heparin low molecular weight (lmw) result was obtained on a patient sample on a bcs xp system. The discordant result was auto-verified and reported to the physician(s). The sample was rerun on the same system twice, resulting higher and within the customer's therapeutic range. The customer averaged the repeat results and reported the average to the physician(s). The sample was also rerun on an alternate bcs xp system, resulting higher and within the customer's therapeutic range. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin lmw result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00081 |
| MDR Report Key | 7780598 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-14 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-08-14 |
| 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 | 2018-08-14 |
| 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 | 2018-08-14 |