MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-20 for ARCHITECT IDIGOXIN 01P32-25 manufactured by Abbott Laboratories.
[120916694]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[120916695]
The customer observed a falsely elevated digoxin (ln 1p32) result for one patient on the architect i2000sr analyzer. The following data was provided from (b)(6): sid (b)(6), initial 3. 5 nmol/l. The doctor took the patient off digoxin for 2 weeks to monitor, yet the patient continued to have critically high levels of digoxin. On (b)(6): result: 3. 5 nmol/l; at another hospital (on siemens analyzer) sample resulted as 0. 2 nmol/l. On (b)(6): result: 3. 2 nmol/l; at another hospital (unknown method) the sample resulted as 0. 3 nmol/l. No other patient details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00140 |
| MDR Report Key | 7895367 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-20 |
| Date of Report | 2018-10-30 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-09-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ARCHITECT IDIGOXIN |
| Generic Name | IDIGOXIN |
| Product Code | KXT |
| Date Received | 2018-09-20 |
| Catalog Number | 01P32-25 |
| Lot Number | 00117K000 |
| Device Expiration Date | 2019-04-26 |
| 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 | 1. Other | 2018-09-20 |