MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-21 for ACTIN FSL B4219-1 manufactured by Dade Behring Gmbh.
[338398]
Incorrect activated partial thromboplastin time result was reported by the lab. Lab user placed the reagents on the analyzer incorrectly, not in accordance with mfr's instructions in both applications sheets and instruction manual. The actin fsl reagent was positioned in the calcium chloride reagent position and vice versa. Erroneous results were obtained and reported. Upon discovering the error. The lab placed the reagent in the correct position on the instrument and retested. The sample. The pt's heparin dose was lowered from 1700 u to 1500 u based on the erroneous result. Heparin was discontinued after the corrected result was received there were no adverse health consequences due to the incorrect test result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2004-00004 |
| MDR Report Key | 550885 |
| Report Source | 05 |
| Date Received | 2004-10-21 |
| Date of Report | 2004-10-18 |
| Date of Event | 2004-09-01 |
| Date Mfgr Received | 2004-09-01 |
| Date Added to Maude | 2004-10-26 |
| 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 | DONNA WOLF |
| Manufacturer Street | P.O. BOX 6101, MS 514 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal | 19714 |
| Manufacturer Phone | 3026310384 |
| Manufacturer G1 | DADE BEHRING MARBURG 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 | ACTIN FSL |
| Generic Name | PARTIAL THROMBOPLASTIN TIME REAGENT |
| Product Code | GIT |
| Date Received | 2004-10-21 |
| Model Number | NA |
| Catalog Number | B4219-1 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 540399 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | ACTIN FSL |
| Baseline Generic Name | ACTIN FSL |
| Baseline Model No | NA |
| Baseline Catalog No | B4219-1 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K863594 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-21 |