MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-06 for DADE ACTIN FSL B4219-2 manufactured by Dade Behring Gmbh.
[19161665]
A falsely elevated aptt result of 70. 2 seconds was obtained on a sample from a patient on heparin. Results were reported to the physician before following lab protocol to repeat the test. The sample was retested with results of 49. 8 and 49. 5 seconds. The patient's heparin dose had been changed based on the original result of 70. 2 seconds, then the dose was changed again when the corrected ptt results were reported. No patient harm was noted. The cause for the elevated aptt result is unknown.
Patient Sequence No: 1, Text Type: D, B5
[19341430]
The cause for the elevated aptt result is unknown. A dade behring representative serviced the device, did not detect an instrument issue and was unable to duplicate the customer problem. The instrument is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2007-00009 |
| MDR Report Key | 891514 |
| Report Source | 05 |
| Date Received | 2007-08-06 |
| Date of Report | 2007-07-25 |
| Date of Event | 2007-07-20 |
| Date Mfgr Received | 2007-07-25 |
| Device Manufacturer Date | 2006-09-26 |
| Date Added to Maude | 2008-01-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANCES DILLON |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK NJ 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026316951 |
| 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 | MA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FSL |
| Generic Name | ACTIVATED PTT REAGENT |
| Product Code | GIT |
| Date Received | 2007-08-06 |
| Model Number | NA |
| Catalog Number | B4219-2 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2008-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 944987 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | MARBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-06 |