MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-20 for MULTIGENT ACETAMINOPHEN 2K99-20 manufactured by Abbott Manufacturing, Inc..
[809590]
The customer is questioning the high lipase quality control results generated on the architect c8000, when it is run in panels. The customer stated that the issue started when the acetaminophen assay is added to the system and the lipase controls were back in range when the acetaminophen assay is removed. The customer followed the troubleshooting instructions mentioned in the customer letter of fa01jun2007 and have some queries about it. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[8028424]
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 | 2018433-2008-00032 |
| MDR Report Key | 1019171 |
| Report Source | 05 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-03-07 |
| Date Mfgr Received | 2008-03-07 |
| Date Added to Maude | 2008-04-17 |
| 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 | SUDARSHAN HEBBAR, MD, D-3QC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| 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 | 2008-03-20 |
| 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 | 994970 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-20 |