MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-20 for ARCHITECT VALPROIC 01P35-26 manufactured by Abbott Laboratories.
[78050103]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[78050104]
The customer reported falsely elevated valproic acid results on one patient. The results provided were: current = 566ug/ml / 2016 = 2. 0ug/ml or less / 2015 = 52ug/ml. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00153 |
| MDR Report Key | 6653356 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-20 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-06-20 |
| 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 | 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 VALPROIC |
| Generic Name | VALPROIC |
| Product Code | LEG |
| Date Received | 2017-06-20 |
| Catalog Number | 01P35-26 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-06-20 |