MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-08 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219-2 manufactured by Dade Behring Gmbh.
[387235]
Erroneous short ptt reuslts of <21 seconds were obtained on the sysmex ca-1500 system. The results were reported to the physician despite the error flags due to user error. Pt was on heparin therapy before the erroneous results were reported but it is unknown if the treatment was altered due to the erroneous results. The pt died. Analysis of instrument data indicates possible sample integrity issue. No additional info could be obtained from the hosp contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00020 |
| MDR Report Key | 634634 |
| Report Source | 05 |
| Date Received | 2005-09-08 |
| Date of Report | 2005-09-07 |
| Date of Event | 2005-08-24 |
| Date Mfgr Received | 2005-08-25 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-09-15 |
| 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 | 3 |
| Manufacturer Contact | VICTOR CARRIO |
| Manufacturer Street | P.O. BOX 6101, MS 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317626 |
| 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 | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | PARTIAL THROMBOPLASTIN TIME REAGENT |
| Product Code | GIT |
| Date Received | 2005-09-08 |
| Model Number | NA |
| Catalog Number | B4219-2 |
| Lot Number | 527336A |
| ID Number | * |
| Device Expiration Date | 2007-02-21 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 624203 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Baseline Generic Name | PARTIAL THROMBOPLASTIN TIME REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | B4219-2 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-09-08 |