MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-07 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219-1 manufactured by Dade Behring Gmbh.
[17766919]
Falsely long ptt results were obtained on 27 pt samples. Quality control samples recovered within customer's established range. Falsely long ptt pt results were reported to a physician. Reagents were incorrectly placed on the analyzer. Once location of reagents were corrected, pts were redrawn and samles were tested. Correct qc and pt results were obtained and reported. One pt was treated with vitamin k. No change in treatment, of the other pts (26), resulted due to the falsely long ptt results. There was no report of adverse health consequences as a result of the falsely long ptt results. Instrument operator placed the actin fsl reagent in the calcium chloride reagent position and vice versa. Issue was resolved by instrument operator placing reagents in the correct position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00002 |
| MDR Report Key | 576852 |
| Report Source | 05 |
| Date Received | 2005-02-07 |
| Date of Report | 2005-02-01 |
| Date of Event | 2005-01-13 |
| Date Mfgr Received | 2005-01-17 |
| Date Added to Maude | 2005-03-02 |
| 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 | AYDEE CRAWFORD |
| Manufacturer Street | P.O. BOX 6101, MS 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026316312 |
| 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 | 2005-02-07 |
| Model Number | NA |
| Catalog Number | B4219-1 |
| 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 | 566693 |
| 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 | 2005-02-07 |