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.
[15033144]
A customer obtained erroneously prolonged aptt results with 10 pt samples. Erroneously prolonged aptt test results have been observed with abnormal citrol controls and pt samples. Unable to determine adverse health consequences to the pts; no additional information has been provided by the customer to indicate that pt sample results were reported to the physician. (note: customer unable to provide date of event).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00029 |
| MDR Report Key | 702459 |
| Report Source | 05 |
| Date Received | 2005-10-17 |
| Date of Report | 2005-10-14 |
| Date Mfgr Received | 2005-09-23 |
| 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 | 691588 |
| 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 |