MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-04-29 for ARCHITECT INSULIN 8K41-26 manufactured by Abbott Laboratories.
[843555]
The customer stated that an initial architect insulin result of 80 uu/ml was generated. The sample was repeated and results of 149 uu/ml and 150 uu/ml were generated.
Patient Sequence No: 1, Text Type: D, B5
[8059998]
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 | 1415939-2008-00058 |
| MDR Report Key | 1036116 |
| Report Source | 01 |
| Date Received | 2008-04-29 |
| Date of Report | 2008-04-03 |
| Date Mfgr Received | 2008-04-03 |
| Date Added to Maude | 2008-08-14 |
| 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-3MQC, 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT INSULIN |
| Generic Name | CMIA QUANTITATION OF HUMAN INSULIN |
| Product Code | CEP |
| Date Received | 2008-04-29 |
| Model Number | NA |
| Catalog Number | 8K41-26 |
| Lot Number | 58020LP17 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1034081 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-29 |