MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-14 for IL TEST PT-FIBRINOGEN 09756710 manufactured by Instrumentation Laboratory Company.
[15703836]
On 07/24/2001, hospital became aware that a miscalculation of laboratory values occurred on 932 pts who were involved in prothrombin time tests between 06/04/2001 and 07/25/2001. The error happened when a wrong factor (or number) was used in an equation to determine lab test results for this specific study only. Following preliminary internal review, hosp officials are reasonably certain, at this time, that two deaths may be linked to this incident. A review is ongoing to determine if there are any other adverse outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 347641 |
| MDR Report Key | 347641 |
| Date Received | 2001-08-14 |
| Date of Report | 2001-08-08 |
| Date of Event | 2001-06-04 |
| Date Facility Aware | 2001-07-25 |
| Report Date | 2001-08-08 |
| Date Reported to FDA | 2001-08-10 |
| Date Reported to Mfgr | 2001-08-10 |
| Date Added to Maude | 2001-08-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IL TEST PT-FIBRINOGEN |
| Generic Name | THROMBOPLASTIN REAGENT |
| Product Code | GGO |
| Date Received | 2001-08-14 |
| Model Number | NA |
| Catalog Number | 09756710 |
| Lot Number | N0216690 |
| ID Number | * |
| Device Expiration Date | 2004-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 336959 |
| Manufacturer | INSTRUMENTATION LABORATORY COMPANY |
| Manufacturer Address | * LEXINGTON MA 024213125 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2001-08-14 |