MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-26 for MULTIGENT ACETAMINOPHEN 2K99-20 manufactured by Abbott Mfg, Inc.
[15161236]
The customer observed a higher than expected lipase control results twice on architect c8000. After removing the multigent acetaminophen assay from the control panel, they got lipase results within the control normal range. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[15393207]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2018433-2007-00049 |
MDR Report Key | 885310 |
Report Source | 05 |
Date Received | 2007-07-26 |
Date of Report | 2007-07-09 |
Date of Event | 2007-05-05 |
Date Mfgr Received | 2007-07-09 |
Date Added to Maude | 2007-09-18 |
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 | 0 |
Event Location | 0 |
Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
Manufacturer Street | 100 ABBOTT PARK RD |
Manufacturer City | ABBOTT PARK IL 600646092 |
Manufacturer Country | US |
Manufacturer Postal | 600646092 |
Manufacturer Phone | 8479379328 |
Single Use | 3 |
Remedial Action | NO |
Previous Use Code | 3 |
Removal Correction Number | 2018433-6/7/07-003-C |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MULTIGENT ACETAMINOPHEN |
Generic Name | ENSYMATIC/COLORIMETRIC METHOD FOR THE QUANTITATIVE DETERMINATION OF ACETAMINOPH |
Product Code | LDP |
Date Received | 2007-07-26 |
Model Number | NA |
Catalog Number | 2K99-20 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 864860 |
Manufacturer | ABBOTT MFG, INC |
Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2007-07-26 |