MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-14 for MULTIGENT ACETAMINOPHEN 2K99-20 manufactured by Abbott Manufacturing, Inc.
[643560]
Customers are receiving falsely elevated lipase results due to the carry over of acetaminophen to lipase when a multigent acetaminophen test is pipetted immediately before a lipase test from the same sample cup or tube on the architect c8000.
Patient Sequence No: 1, Text Type: D, B5
[7958738]
This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00029 |
| MDR Report Key | 865315 |
| Report Source | 07 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-05-18 |
| Date Mfgr Received | 2007-05-18 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2007-07-18 |
| 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 ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | ENZYMATIC/COLORIMETRIC METHOD FOR THE QUANTITATIVE DETERMINATION OF ACETAMINOPHE |
| Product Code | LDP |
| Date Received | 2007-06-14 |
| Model Number | NA |
| Catalog Number | 2K99-20 |
| Lot Number | 31046UQ02 |
| ID Number | 30455UQ11 |
| Device Expiration Date | 2008-04-30 |
| 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 | 858936 |
| Manufacturer | ABBOTT MANUFACTURING, INC |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |