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 2017-10-06 for INNOVANCE D-DIMER CONTROLS 10446006 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[89937282]
A siemens healthcare diagnostics inc. (siemens) technical support technician (tst) analyzed the event to determine the cause of the high, out of range recovery of d-dimer control level 2 on the sysmex ca-1500 system. The tst determined that the quality controls (qc) ranges were incorrectly set on the system. On (b)(6) 2017, the customer calibrated a new reagent lot and started new qc lots. The customer did not update the system's quality control file with the new lots' table of assigned values (tav) ranges. Using the previous lots' tav ranges, the customer ran qc and patient samples. The customer ran patient samples and reported results when d-dimer control level 2 recovered out of range. As per the tst's instructions, the customer replaced the lamp, recalibrated the assay, corrected the qc ranges and ran qc, which recovered within expected ranges. The cause of the high, out of range recovery of d-dimer control level 2 is user error. The system is performing according to specifications. No further evaluation of this system is required. Mdr 9610806-2017-00111 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[89937283]
A customer reported high, out of range recovery of d-dimer control level 2 on the sysmex ca-1500 system after changing quality control (qc) lots on (b)(6) 2017. D-dimer control level 1 was always within the table of assigned values (tav) range. Patient samples were run and results were reported to the physician(s) while the level 2 qc was out of range. The physician(s) did not question the results. There are no known reports of patient intervention or adverse health consequences due to the potentially discordant d-dimer results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00110 |
| MDR Report Key | 6922077 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-06 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-11 |
| Date Added to Maude | 2017-10-06 |
| 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 | 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 CONTROLS |
| Generic Name | INNOVANCE D-DIMER CONTROLS |
| Product Code | DAP |
| Date Received | 2017-10-06 |
| Model Number | INNOVANCE D-DIMER CONTROLS |
| Catalog Number | 10446006 |
| Lot Number | 47454 |
| Device Expiration Date | 2019-03-21 |
| 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 | 2017-10-06 |