MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,08 report with the FDA on 2003-10-20 for THROMBOMAX HS WITH CALCIUM T9686 manufactured by Sigma Aldrich, Co..
[331326]
Incorrect isi mechnical and optical values were printed on the package insert. Comparison of values: incorrect isi value, mechanical: 1. 01. Optical: 0. 96, correct isi value: mechanical: 1. 25, optical: 1. 17. Isi values are used to adjust prothrombin time measures, which are clinically relevant to clotting time of blood. These clotting times are used with other clinical indicators to assess and/or adjust blood therapeutics, including thinners such as coumadin. The incorrect values of isi may lead to clotting time(s) adjustment lower (less time) than actual, thereby potentially indicating increase dosage of blood thinners. Regarding the malfunction, no such events have been reported to date for this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1938173-2003-00001 |
| MDR Report Key | 491234 |
| Report Source | 03,08 |
| Date Received | 2003-10-20 |
| Date of Report | 2003-09-18 |
| Date Mfgr Received | 2003-09-18 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2003-10-27 |
| 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 | JESSICA LOVE |
| Manufacturer Street | 545 S. EWING AVE |
| Manufacturer City | SAINT LOUIS MO 63103 |
| Manufacturer Country | US |
| Manufacturer Postal | 63103 |
| Manufacturer Phone | 8003253010 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THROMBOMAX HS WITH CALCIUM |
| Generic Name | THROMBOPLASTIN REAGENT |
| Product Code | GGO |
| Date Received | 2003-10-20 |
| Model Number | NA |
| Catalog Number | T9686 |
| Lot Number | 102K6071 |
| ID Number | NA |
| Device Expiration Date | 2004-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 479947 |
| Manufacturer | SIGMA ALDRICH, CO. |
| Manufacturer Address | * ST. LOUIS MO * US |
| Baseline Brand Name | THROMBOMAX HS WITH CALCIUM |
| Baseline Generic Name | THROMBOPLASTIN REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | T9686 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-20 |