MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-29 for TDX/TDXFLX METHOTREXATE II 7A12-60 manufactured by Abbott Diagnostics Int'l, Ltd.
[1122606]
Revision surgery - pt was experiencing pain with the tibia. Surgeon decided to re-cut the tibia.
Patient Sequence No: 1, Text Type: D, B5
[1179477]
The customer states that an order for the measurement of methotrexate was received by the lab for testing with the tdxflx methotrexate ii assay. The laboratory technician tested the sample for amikacin instead and reported a result out of the lab of <0. 02 umol/l. A second sample was drawn and a methotrexate level was ordered but the same technician tested the sample for amikacin and reported a result of <0. 02 umol/l out of the lab. The hospital pharmacist questioned these results because the patient was taking methotrexate. The patient received an overdose of methotrexate as a result with subsequent drugs given to the patient as a rescue treatment. The patient recovered. The two samples were then retested with the methotrexate ii assay with the first sample generating a methotrexate result of 14. 51 umol/l and the second sample generating a methotrexate result of 7. 38 umol/l. The customer stated that this was an error on the part of the technician and not an instrument error. The customer reported no other cases of incorrect assays being run. There is no other impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8304996]
Analytical testing is not required for this evaluation, as a review of quality data will be sufficient to determine whether a product malfunction exists. Complaint activity was reviewed and identified no adverse trends in association with the issue currently under evaluation. No other complaints have been documented for running the incorrect assay, for reporting out patient results when having run the incorrect assay or for a patient receiving a treatment based off of incorrect results. A risk evaluation was completed by the customer site to evaluate the technician error. Based on the results of this investigation, the tdx/tdxflx methotrexate ii assay is performing as intended and no product malfunction was identified. No further investigation is required. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
[8369450]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2009-00090 |
| MDR Report Key | 1486195 |
| Report Source | 05 |
| Date Received | 2009-09-29 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-09-01 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2009-11-17 |
| 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 KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Street | KM 58.0 CARRETERA 2 CRUCE DAVILA |
| Manufacturer City | BARCELONETA PR 00617 |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX METHOTREXATE II |
| Generic Name | FOR THE MEASUREMENT OF METHOTREXATE IN HUMAN SERUM OR PLASMA |
| Product Code | LAO |
| Date Received | 2009-09-29 |
| Catalog Number | 7A12-60 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 00617 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-29 |