MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-10-17 for DADE ACTIN FS ACTIVATED PTT REAGENT B4218-100 manufactured by Dade Behring Gmbh.
[445531]
A customer obtained erroneously prolonged aptt results with a pt sample and controls. Plasma controls were out of range and the erroneous pt results were not reported to the physician. There were no adverse health consequences to the pt; treatment was not prescribed or altered based on the erroneous results. (note: customer unable to provide date of event).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00022 |
| MDR Report Key | 702453 |
| Report Source | 05 |
| Date Received | 2005-10-17 |
| Date of Report | 2005-10-07 |
| Date Mfgr Received | 2005-08-25 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-04-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AYDEE CRAWFORD |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026316312 |
| Manufacturer G1 | DADE MARBURG GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-10/07/05-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Generic Name | ACTIVATED PARTIAL THROMBOPLASTIN TIME |
| Product Code | GIT |
| Date Received | 2005-10-17 |
| Model Number | NA |
| Catalog Number | B4218-100 |
| Lot Number | 527263 |
| ID Number | NA |
| Device Expiration Date | 2006-02-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 691582 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Baseline Generic Name | ACTIVATED PARTIAL THROMBOPLASTIN TIME |
| Baseline Model No | NA |
| Baseline Catalog No | B4218-100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-17 |