MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-05-01 for TDX/TDXFLX METHOTREXATE II 07A12-60 manufactured by Abbott Laboratories.
[4360008]
The customer observed a falsely depressed methotrexate result for one patient on the tdx/flex analyzer. The following data was provided: initial result = 1 (april 8, drug recently administered, but no specifics about date and time were (b)(6) was high, diluted and ran as 96 and 839 um/l. Repeated at another lab as 926. 38 um/l. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[11757220]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[28699139]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. Accuracy testing met all specifications. Complaint information reasonably suggests the assay is performing as intended, and no malfunction of the device occurred. Based on the available information, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2014-00098 |
| MDR Report Key | 3785214 |
| Report Source | 01,05 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-04-11 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2014-07-25 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-06-20 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX METHOTREXATE II |
| Generic Name | METHOTREXATE |
| Product Code | LAO |
| Date Received | 2014-05-01 |
| Catalog Number | 07A12-60 |
| Lot Number | 31313M501 |
| Device Expiration Date | 2014-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-01 |