MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-15 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[77649218]
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
[77649219]
The customer reported falsely elevated paracetamol (non-abbott acetaminophen assay) results on one patient. The results provided were: (b)(6) on (b)(6) 2017 at 20:46pm = 215. 78 / repeated (b)(6) 2017 at 02:48am = 4. 77. The initial results were released to the ward and the patient was treated. There is no information on if the patient had any adverse effects due to the treatment, therefore, per medical opinion a serious injury could not be ruled out. There was no additional patient information provided. The patient was treated for the elevated paracetamol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00260 |
| MDR Report Key | 6643454 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2017-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2017-06-15 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-15 |
| Catalog Number | 03L77-01 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-15 |