MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-10-27 for TDX/TDXFLX METHOTREXATE II 07A12-60 manufactured by Abbott Diagnostics International Ltd.
[2220699]
The customer stated that falsely decreased tflx methotrexate results were generated from a pediatric patient after infusion. A result of 4 umol/l was generated one hour after the infusion, was repeated at 3. 6 umol/l and reported out. The result was questioned and the sample was retested after manual dilution with an accepted result of 80 umol/l. Another result of 0. 02 umol/l was obtained 24 hours after the infusion. The result was reported out and questioned by the patient physician. The sample was then retested with an accepted result of 0. 79 umol/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[9368170]
(b)(4). Product evaluation is in process and the results will be submitted in the final report once the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[18017914]
Product evaluation was conducted to evaluate this issue. The lot search did not identify any atypical activity for the likely cause lot. Additionally no adverse trends or non-statistical trends were identified related to the issue under investigation. The abbott controls out of range protocol was performed for accuracy testing using likely cause lot 01222q101 and the testing met acceptance criteria. Based on this investigation tdxflx lot 01222q101 is performing as intended. No additional issues were identified and no product deficiency was identified related o the malfunction reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2011-00500 |
| MDR Report Key | 2310853 |
| Report Source | 01 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-10-03 |
| Date Mfgr Received | 2011-11-29 |
| Date Added to Maude | 2012-01-24 |
| 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 DIAGNOSTICS INTERNATIONAL LTD |
| Manufacturer Street | KM 58.0 CARRETERA 2 CRUCE DAVILA |
| Manufacturer City | BARCELONETA PA 00617 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX METHOTREXATE II |
| Product Code | LAO |
| Date Received | 2011-10-27 |
| Catalog Number | 07A12-60 |
| Lot Number | 01222Q101 |
| 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 DIAGNOSTICS INTERNATIONAL LTD |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PA 00617 US 00617 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-27 |