MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-21 for DADE ACTIN FSL B4219-2 manufactured by Dade Behring Gmbh.
[17027504]
A falsely depressed aptt result of 20 sec. Was obtained on a sample from a patient receiving heparin. Despite the results being flagged by the instrument, the customer reported them to the physician. The physician did not question the results. A new sample was tested and a result of 75 sec. Was obtained. The 75 sec. Result was confirmed by alternate methodology. The patient received a bolus of heparin and bled. No permanent harm was done. Analysis of the instrument and instrument data indicate that the cause of the falsely depressed aptt was user error.
Patient Sequence No: 1, Text Type: D, B5
[17285128]
No further evaluation of the device is required. Analysis of the instrument and instrument data indicate that the cause of the falsely depressed aptt was user error. The instrument is operating within specifications
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2007-00002 |
| MDR Report Key | 843140 |
| Report Source | 05 |
| Date Received | 2007-02-21 |
| Date of Report | 2007-01-31 |
| Date of Event | 2007-01-31 |
| Date Mfgr Received | 2007-01-31 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2007-05-02 |
| 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 | 0 |
| Manufacturer Contact | CAROLYN CHASTAIN |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318789 |
| Manufacturer G1 | DADE BEHRING GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FSL |
| Generic Name | ACTIVATED PTT REAGENT |
| Product Code | GIT |
| Date Received | 2007-02-21 |
| Model Number | NA |
| Catalog Number | B4219-2 |
| Lot Number | 527338A |
| ID Number | NA |
| Device Expiration Date | 2007-03-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 830306 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-21 |