MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-28 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 manufactured by Dade Behring Gmbh.
[401669]
Falselu prolonged a ptt results were obtained on 6 patient samples and were reported to the physician. Quality control samples recovered within range. The customer discovered that actin fsl and calcium chloride reagents were placed in the wrong positions on the analyzer. The actin fsl reagent was placed in the calcium chloride position and vice versa. Once reagents were placed in the correct positions, the 6 samples were re-tested. Correct qc and patient results were obtained and reported. There was no report of adverse health consequences as a result of the falsely prolonged aptt results that were initially reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00003 |
| MDR Report Key | 583858 |
| Report Source | 05 |
| Date Received | 2005-02-28 |
| Date of Report | 2005-02-25 |
| Date of Event | 2005-02-09 |
| Date Mfgr Received | 2005-02-10 |
| Date Added to Maude | 2005-03-23 |
| 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 | YUK-TING LEWIS |
| 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 |
| 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 | 2005-02-28 |
| Model Number | NA |
| Catalog Number | B4219 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 573684 |
| 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 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-28 |