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 2016-07-13 for INNOVANCE(R) D-DIMER OPBP35 SMN10445979 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[49394640]
The cause of the biased low d-dimer results is user error. The initial result was flagged and should not have been reported without further investigation. The event involved a patient sample specific issue. Examination of instrument data revealed an artifact at the beginning of measurement that led to a predilution of the sample with a dilution factor of 1:19 causing the falsely depressed result. This unnecessary high dilution led to result inaccuracy. The customer stated that there were unaware of any negative effect on patient outcome/treatment other than no further evaluation for deep vein thrombosis (dvt) or pulmonary embolism (pe). The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[49394641]
A falsely depressed d-dimer result was obtained on a patient sample on the cs-2100i system. The result was flagged for review but reported to the physician. The sample was repeated after ultracentrifugation and a higher result was obtained. Patient treatment was altered on the basis of the falsely depressed d-dimer result. There was no further assessment conducted for deep vein thrombosis (dvt) or pulmonary embolism (pe) due to the falsely depressed result. There was no report of adverse health consequences as a result of the falsely depressed d-dimer result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00022 |
| MDR Report Key | 5789905 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-13 |
| Date of Report | 2016-07-13 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-06-15 |
| Device Manufacturer Date | 2015-09-07 |
| Date Added to Maude | 2016-07-13 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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(R) D-DIMER |
| Generic Name | INNOVANCE(R) D-DIMER |
| Product Code | DAP |
| Date Received | 2016-07-13 |
| Catalog Number | OPBP35 SMN10445979 |
| Lot Number | 45404 |
| Device Expiration Date | 2017-06-28 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2016-07-13 |