MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-02-24 for SIMPLASTIN EXCEL 252001 manufactured by Biomerieux, Inc..
[20990684]
Simplastin excel is a thromboplastin reagent. An erroneous result was obtained on an energency room patient with simplastin excel. The result was reported to the physician. The technician thought the results were abnormally low and reconstituted a new vial and tested a second time on the patient sample. The results from the second test were immediately given to the physician. There were no adverse effects to the patient from the first reported result. The technician inspected the vial that gave the abnormal results and it ws cracked. The technician did not notice the cracked vial before the erroneius result was reported to the physician and no controls were run before the vial change-over.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00004 |
| MDR Report Key | 578265 |
| Report Source | 07 |
| Date Received | 2005-02-24 |
| Date of Report | 2005-02-24 |
| Date of Event | 2005-02-03 |
| Date Mfgr Received | 2005-02-03 |
| Date Added to Maude | 2005-03-07 |
| 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 | 3 |
| Manufacturer Contact | AMANDA KIEBY |
| Manufacturer Street | 100 RODOLPHE |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202053 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLASTIN EXCEL |
| Generic Name | THROMBOPLASTIN REAGENT |
| Product Code | GGO |
| Date Received | 2005-02-24 |
| Model Number | NA |
| Catalog Number | 252001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 568114 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | SIMPLASTIN EXCEL |
| Baseline Generic Name | THROMBOPLASTIN REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 252001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-24 |