MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-01-08 for INNOVANCE(R) ANTITHROMBIN REAGENT OPFH manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[3058817]
The customer complains of decreasing qc values for innovance antithrombin (at) with results decreasing out of acceptance ranges after 24 hours. It is unknown if patient samples were reported. The customer reports they have switched to testing on an alternate instrument system. It is unknown if patient treatment was altered or prescribed on the basis of falsely depressed at results. There is no report of adverse outcome to the patient as a result of the falsely depressed results.
Patient Sequence No: 1, Text Type: D, B5
[10424787]
The cause of the falsely depressed antithrombin results is unknown. The reagent issue is under investigation by siemens healthcare diagnostics inc. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00001 |
| MDR Report Key | 2901348 |
| Report Source | 01,05,06 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-09 |
| Date of Event | 2012-12-09 |
| Date Mfgr Received | 2012-12-09 |
| Date Added to Maude | 2013-04-01 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 76 EMIL VON BEHRING STRASSE |
| 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(R) ANTITHROMBIN REAGENT |
| Generic Name | INNOVANCE(R) ANTITHROMBIN REAGENT |
| Product Code | JBQ |
| Date Received | 2013-01-08 |
| Catalog Number | OPFH |
| Lot Number | 41736 |
| Device Expiration Date | 2013-07-12 |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-08 |