MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-28 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[2273297]
The account generated a falsely depressed tdxflx methotrexate result of 0. 45 (no units of measurement given) on a 24 hour post dose specimen, which was reported outside of the laboratory. Through troubleshooting, the specimen was processed again with a tdxflx methotrexate result of 0. 84, 3. 64, 3. 89 (no units of measurement given). A corrected report of 3. 89 was submitted to the physician. No treatment was given based on the tdxflx methotrexate depressed result of 0. 45 (no units of measurement given). The laboratory provided ranges are 24 hours post dose = 5 - 10 (no units of measurement given), 48 hours post dose = 0. 5 -1 (no units of measurement given), 72 hours post dose = <0. 2 (no units of measurement given). No specific patient information was provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[9565465]
Low test results ; (b)(4) no consequences or impact to patient ; (b)(4). The evaluation is in process. A followup mdr will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[9681763]
An abbott field service representative replaced the tdxflx probe and boom assembly to resolve the issue. A labeling review found the tdxflx system operation manual contains adequate information for resolving discrepant result issues. The labeling review also found the methotrexate ii package insert contains adequate information. A historical/quality data review of 12 months of complaint documentation did not find any similar complaints for tdxflx methotrexate discrepant results. A review of the tdxflx serial no (b)(4) service history found no additional discrepant result complaints have been documented for tdxflx serial number (b)(4), since the fsr replaced the probe and boom assembly. The service history review found no trend of issues with tdxflx serial no (b)(4). (b)(4). Based on the available information and this evaluation, no deficiency was identified for the tdxflx analyzer list number 04a24-96, the tdxflx probe list no 09967-02, or the tdxflx boom assembly part no 3-45002-01 for the issue under evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00718 |
| MDR Report Key | 2350106 |
| Report Source | 05 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-11-02 |
| Date Mfgr Received | 2011-12-08 |
| Device Manufacturer Date | 2006-11-20 |
| Date Added to Maude | 2012-07-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDXFLX SYSTEM |
| Product Code | LAO |
| Date Received | 2011-11-28 |
| Catalog Number | 04A24-96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-28 |