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 2017-09-13 for INNOVANCE? D-DIMER 10445982 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[86845316]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) and a technical application specialist (tas) were dispatched to the customer's site to determine the cause of the potential false negative d-dimer results on the bcs xp system. During the investigation, the cse observed that the calibration curve, used to run patient samples, on the bcs xp system was unacceptable. The cse changed the reagent lot, calibrated the system, replaced the sample probes, and flushed the bcs xp system of the barbicide disinfectant cleaner. The precision test, validation and lamp were within specifications. The internal qc recovered within expected ranges. Upon further investigation, siemens determined that the customer is using recycled cuvette rotors. Based on the bcs? Xp system's instruction manual, cuvettes are only intended for single use. If used more than once, this could result in inaccurate measurement results. The use of recycled cuvette rotors is a user error and potentially contributed to the discordant result. Siemens has instructed the customer to discontinue the use of recycled cuvette rotors. The system is performing according to specifications. No further evaluation of this system is required. Mdr 9610806-2017-00098, mdr 9610806-2017-00099, mdr 9610806-2017-00101, and mdr 9610806-2017-00102 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[86845323]
Multiple potential false negative d-dimer results were obtained on multiple patient samples using an unacceptable calibration curve on the bcs xp system. The d-dimer results were reported to the physician(s), who did not question the results. The affected patient samples were not rerun and corrected reports were not provided to the physician(s). The correct results for the affected patients are unknown. There are no known reports of patient intervention or adverse health consequences due to the potential false negative d-dimer results obtained on the patient samples on the bcs xp system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00100 |
| MDR Report Key | 6861377 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-13 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-09-18 |
| Date Added to Maude | 2017-09-13 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVANCE? D-DIMER |
| Generic Name | INNOVANCE? D-DIMER |
| Product Code | DAP |
| Date Received | 2017-09-13 |
| Model Number | INNOVANCE? D-DIMER |
| Catalog Number | 10445982 |
| Lot Number | 47386 |
| Device Expiration Date | 2019-02-26 |
| 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 | 2017-09-13 |