MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for TDX/TDXFLX METHOTREXATE II 07A12-60 manufactured by Abbott Laboratories.
[77524532]
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process. A follow up report will be submitted when the evaluation is complete. Please note: this same patient/event is submitted under a second suspect medical device in manufacturer report number 1628664-2017-00248.
Patient Sequence No: 1, Text Type: N, H10
[77524533]
The customer observed a falsely elevated methotrexate results on the tdx analyzer. The following data was provided: sid (b)(6) initial 9. 41 micromol/l, repeat 0. 55 mmol/l and 0. 11 after 72 hours. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00131 |
| MDR Report Key | 6631005 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-14 |
| Date Mfgr Received | 2017-06-21 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2017-06-09 |
| 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 | 3 |
| 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 | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| 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 | 2017-06-09 |
| Catalog Number | 07A12-60 |
| Lot Number | 67031M501 |
| Device Expiration Date | 2017-11-08 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |