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 2019-05-09 for CREATININE 03L81-32 manufactured by Abbott Manufacturing Inc.
[144572594]
Complete information for section a, patient information, patient identifier sid (b)(6) an evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[144572595]
The customer reported falsely elevated creatinine results on one patient on the architect analyzer. The results provided were: sid (b)(6) on (b)(6) 2019 creatinine = 793 / 762 / 753umol/l; new sample on (b)(6) 2019 creat = 96. 9umol/l. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1628664-2019-00362 |
MDR Report Key | 8594909 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-05-09 |
Date of Report | 2019-08-15 |
Date of Event | 2019-04-15 |
Date Mfgr Received | 2019-08-13 |
Device Manufacturer Date | 2018-10-11 |
Date Added to Maude | 2019-05-09 |
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 |
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 | 2019-05-09 |
Catalog Number | 03L81-32 |
Lot Number | 03282UN18 |
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 | 2019-05-09 |