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 2017-10-20 for INNOVANCE HEPARIN 10873448 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[90675327]
Siemens healthcare diagnostics inc. Is investigating the cause of the discordant, low innovance heparin patient result that was generated on the cs-2500 coagulation analyzer.
Patient Sequence No: 1, Text Type: N, H10
[90675328]
A discordant, low heparin patient result (0. 47 iu/ml) using innovance heparin kit lot 46475 was generated on the cs-2500 coagulation analyzer compared to the heparin patient result (0. 83 iu/ml) generated with berichrom heparin kit lot 47293. The innovance heparin patient result (0. 47iu/ml) was reported to the physician. The same patient sample was processed at the same time by the both methods on the same cs-2500 coagulation analyzer on the same day. The patient result generated with innovance heparin kit lot 46475 did not match the clinical expectation of the patient. The heparin result expected was ~0. 80 iu/ml. There was no known impact or adverse health consequence to the patient due to the reported low innovance heparin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00121 |
| MDR Report Key | 6964424 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2016-08-04 |
| Date Added to Maude | 2017-10-20 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVANCE HEPARIN |
| Generic Name | INNOVANCE HEPARIN |
| Product Code | KFF |
| Date Received | 2017-10-20 |
| Catalog Number | 10873448 |
| Lot Number | 46475 |
| Device Expiration Date | 2017-12-15 |
| 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 STRASSE 76 MARBURG, GM 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |