MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-09 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[3031385]
A discrepant low aptt clotting time result was reported on a patient sample. After the discrepancy was discovered, the same sample was repeated and a more prolonged result was obtained. The patient was treated on the basis of the initially discrepant low result. The patient's heparin dosage was increased. The heparin dosage was re-adjusted after the discrepancy was identified. There is no report of adverse outcome to the patient as a result of the falsely low result and treatment.
Patient Sequence No: 1, Text Type: D, B5
[10302526]
The cause of the falsely depressed aptt result reporting was user error. The account reports that the discrepant low aptt result was resulted to the floor because a wrong id was manually entered into the software and autoverified. When the correct tube was run and had a prolonged appt result, the result was not resulted because the discrepant result had already been reported. The instrument and software is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2012-00017 |
| MDR Report Key | 2827108 |
| Report Source | 05,06 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-09-23 |
| Date Mfgr Received | 2012-10-17 |
| Device Manufacturer Date | 2011-10-28 |
| Date Added to Maude | 2013-02-15 |
| 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 | 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 | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2012-11-09 |
| Catalog Number | B4219 |
| Lot Number | 547324 |
| Device Expiration Date | 2013-10-06 |
| 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 | 2012-11-09 |