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 2019-04-09 for CREATININE 03L81-22 manufactured by Abbott Manufacturing Inc.
[141452707]
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
[141452708]
The customer observed falsely elevated creatinine results on the architect c4000 analyzer. The following data was provided: sid (b)(6) initial 2. 91, repeat 0. 87, 0. 87 mg/dl. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00292 |
| MDR Report Key | 8497343 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-09 |
| Date of Report | 2019-08-07 |
| Date Mfgr Received | 2019-08-06 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2019-04-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| 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 | CREATININE |
| Generic Name | CREATININE |
| Product Code | CGX |
| Date Received | 2019-04-09 |
| Catalog Number | 03L81-22 |
| Lot Number | 64131UN18 |
| Device Expiration Date | 2019-11-22 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |