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 2018-11-05 for INNOVANCE D-DIMER 10445981 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[127906981]
The customer contacted a siemens customer care center (ccc) to report that a discordant, falsely low d-dimer result was obtained on a patient sample on a sysmex ca-1500 system using the innovance d-dimer reagent. The customer properly filled the sample, it was not lipemic, icteric or hemolyzed. Siemens determined that quality controls (qcs) were within expected ranges on the day of event. Siemens determined that inadequate mixing, centrifuging or other sample handling issues could be the contributing factors to the discordant result. Inadequate sample mixing can lead to erroneous results due to micro clots or latent fibrin formation in the plasma portion of the sample. The customer did not report issues with any other assays on this instrument. The cause of the discordant, falsely low d-dimer result is unknown. The reagent is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[127906982]
A discordant, falsely low d-dimer result was obtained on a patient sample when the sample was diluted and repeated on a sysmex ca-1500 system, using the innovance d-dimer reagent. When the sample was initially run, a higher d-dimer result was obtained on the patient sample. The discordant result was reported to the physician(s) and recalled before the physician(s) saw the result. The sample was repeated multiple times on the same system under different sample ids, resulting higher. The repeat result of 4. 09 was reported, as the correct result, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00114 |
| MDR Report Key | 8039059 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-11-05 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT 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 | 2018-11-05 |
| Model Number | INNOVANCE D-DIMER |
| Catalog Number | 10445981 |
| Lot Number | 48194 |
| Device Expiration Date | 2019-11-05 |
| 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 PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-05 |