MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-14 for MULTIGENT ACETAMINOPHEN 2K99-20 manufactured by Abbott Manufacturing, Inc.
[19160769]
The customer states that lipase controls are out of range high when they are run on the architect c8000. When controls are return on the instrument individually, they are within the normal range. In addition, a patient sample generated a higher than expected lipase result, but when the same sample was retested, an expected result was obtained. There was no impact to the patient's management reported.
Patient Sequence No: 1, Text Type: D, B5
[19517938]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00032 |
| MDR Report Key | 865314 |
| Report Source | 05 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-03-14 |
| 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 | 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 | 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 | 30455UQ11 |
| ID Number | NA |
| 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 | 858934 |
| Manufacturer | ABBOTT MANUFACTURING, INC |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |