MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-27 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[91073932]
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
[91073933]
The customer observed falsely depressed potassium while using the architect c16000 analyzer ict module. The following data was provided. (b)(6): potassium (k) 1. 5 repeat using another architect c16000 analyzer showed results in the normal range (3. 5 to 5. 1 mmol/l), however the specific results were not provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1628664-2017-00404 |
MDR Report Key | 6985573 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2017-10-27 |
Date of Report | 2017-11-09 |
Date of Event | 2017-10-04 |
Date Mfgr Received | 2017-10-29 |
Device Manufacturer Date | 2013-01-01 |
Date Added to Maude | 2017-10-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 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 | CEM |
Date Received | 2017-10-27 |
Catalog Number | 03L77-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
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 | 2017-10-27 |
Catalog Number | 03L77-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
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 | 2017-10-27 |