MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-05-15 for ARCHITECT INSULIN 8K41-26 manufactured by Abbott Laboratories.
[867242]
The account generated a architect insulin result of 70 uu/ml on a specimen that tested axsym insulin of 40 uu/ml. The account is questioning the high architect insulin result. The architect insulin result was not reported outside of the laboratory. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7999685]
(investigation in process, no conclusion can be drawn). Third party relationship: abbott laboratories, abbott diagnostics division, has entered into an agreement with denka seiken co. Ltd for the mfr of the architect insulin assay. 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 | 1415939-2008-00064 |
| MDR Report Key | 1047964 |
| Report Source | 01 |
| Date Received | 2008-05-15 |
| Date of Report | 2008-04-22 |
| Date Mfgr Received | 2008-04-22 |
| Date Added to Maude | 2008-09-30 |
| 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 ROAD |
| 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 | 2008-05-15 |
| Model Number | NA |
| Catalog Number | 8K41-26 |
| Lot Number | 60020LP18 |
| ID Number | NA |
| 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 | 1044554 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-15 |