MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-06-14 for MULTIGENT ACETAMINOPHEN 2K99-20 manufactured by Abbott Manufacturing, Inc..
[16111421]
The customer states that they are getting erratic lipase control results on the architect c8000. After removing the multigent acetaminophen assay from the control panel, they got results within the lipase control normal range. There was no impact to patient's management reported.
Patient Sequence No: 1, Text Type: D, B5
[16201563]
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 | 2018433-2007-00035 |
| MDR Report Key | 865311 |
| Report Source | 04 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-03-02 |
| 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 | 0 |
| 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 | OTHER |
| 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 | 858921 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |