MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-09 for INNOVANCE D-DIMER SMN10445980 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[59509445]
The cause of the discrepant falsely depressed d-dimer result is unknown. However, analysis of the instrument data revealed no systematic failures or qc failures. The issue is an isolated observation of a patient measurement with a falsely low d-dimer result in a single determination which is discordant to other measurements. The cause of the issue seems to be related to the affected 2nd sample. This sample is described as having a high count of fibrin monomers. Fibrin monomers are an intermediates in the fibrinogen activation to fibrin and may cause microclots. Samples with microclots may cause sample under-aspiration by pipettor clogging and by this may deliver false low results. Microclots can be removed by correct sample preparation with centrifugation, and therefore the presence of microclots is a preanalytical issue which is under the user's responsibility. In addition, as the patient has a known malignancy suspected for dic/sepsis, the results of such samples have to be interpreted with caution as these disease stages are known to potentially interfere with d-dimer analysis as indicated in the 'summary and explanation' section of the instructions for use. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[59509446]
A discrepant low d-dimer result was obtained on a patient sample on the cs-5100 instrument. The result was not reported to the physician. The same sample was retested and a higher result was obtained and reported. There is no indication that patient treatment was altered or prescribed on the basis of the discrepant low d-dimer result. There was no report of adverse health consequences as a result of the discrepant low d-dimer result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00034 |
| MDR Report Key | 6089858 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-09-23 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2015-12-10 |
| Date Added to Maude | 2016-11-09 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 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 | 2016-11-09 |
| Catalog Number | SMN10445980 |
| Lot Number | 45736 |
| Device Expiration Date | 2017-10-11 |
| 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 STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |