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 2018-04-06 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[105256329]
The customer contacted siemens customer care center (ccc) and reported that they obtained different activated partial thromboplastin time (aptt) results for a patient on the bcs xp system. Upon obtaining different results on the patient samples, the customer ran quality controls (qcs), resulting within expected ranges. As per the siemens technical solutions center (tsc) specialist's instructions, the customer ran a validation test, which recovered as expected. Since qc recovery and the validation test recovered within specification, the tsc specialist determined that there was no indication of a system or reagent malfunction. The customer declined further investigation and indicated that the sample draws were potentially mixed; this sample handling use error potentially contributed to the different results obtained on samples from the affected patient. The system and reagent are performing according to specifications. No further evaluation of these devices is required.
Patient Sequence No: 1, Text Type: N, H10
[105256330]
Two samples (sample id (sid) (b)(4) and sid (b)(4)) from the same patient were run and repeated for activated partial thromboplastin time (aptt) on the bcs xp system using the dade actin fsl activated ptt reagent. The samples were identified with different types of sample barcodes and the aptt results obtained on sid (b)(4) did not match aptt results obtained on sid (b)(4). The initial results were reported to the pharmacist(s), who questioned the results as they observed differences in the results. These results were not used to monitor the patient's heparin therapy and the customer reported that the physician(s) stopped the patient's heparin drip. The correct aptt result for this patient is unknown as the patient was not redrawn to verify either result. There are no known reports of patient intervention or adverse health consequences due to the different aptt results obtained on samples from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00039 |
| MDR Report Key | 7402591 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-06 |
| 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 |
| 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 | 2018-04-06 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10459330 |
| 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 | 2018-04-06 |