MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-10 for TDX/TDXFLX METHOTREXATE II 7A12-60 manufactured by Abbott Diagnostics International, Ltd..
[712698]
Through complaint investigation, we confirmed that there was an issue with the kit configuration for lot 45050q100. Each 100-test kit should contain 4 bottles configured as w-s-t-p. The complaint investigation showed the kits were configured incorrectly as s-w-t-p. When customers use a tdx/tdxflx methotrexate ii reagent lot 45050q100 with the bottles w and s in the incorrect order (s-w-t-p), pt results may be falsely increased or decreased, controls will run out of range, and a calibration curve cannot be generated. A recall was issued and reported to the fda district on april 2, 2007. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8120692]
This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2007-00001 |
| MDR Report Key | 935467 |
| Report Source | 07 |
| Date Received | 2007-04-10 |
| Date of Event | 2007-03-20 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-11-01 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-40207-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX METHOTREXATE II |
| Generic Name | FPIA FOR THE QUANTITATIVE MEASUREMENT OF METHOTREXATE |
| Product Code | LAO |
| Date Received | 2007-04-10 |
| Model Number | NA |
| Catalog Number | 7A12-60 |
| Lot Number | 45050Q100 |
| ID Number | NA |
| Device Expiration Date | 2008-01-01 |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 907525 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-10 |