MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-06-17 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[19404849]
The customer questioned the higher than expected architect insulin results generated from one patient sample. The customer stated that a result of 26 uiu/ml was suspected since the patient has a result of 0. 01 ng/ml for the c-peptide assay. The customer indicated that the patient did not take any medication that could have an effect on the insulin results. The customer then performed a dilution and results of 34. 1 and 24. 4 were then generated for the insulin. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[19454183]
(b)(4). Product evaluation is in process and the results will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[25060175]
Product evaluation was performed in order to investigate this issue. Review of ticket trending and a lot search did not identify atypical complaint activity related to this issue. Accuracy testing was completed using retained kits of reagent lot 37020lp55. Acceptance criteria were met, which indicates acceptable product performance. A deficiency was not identified as panel testing shows that the likely cause lot performed per specification. No malfunction is suggested since this issue was limited to a discreet patient sample and assay values obtained through a dilution study performed by the customer generated similar results. There is no performance claim for this assay and additional issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[26508685]
Product evaluation is in process and the results will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2014-00126 |
| MDR Report Key | 3878373 |
| Report Source | 01 |
| Date Received | 2014-06-17 |
| Date of Report | 2014-05-29 |
| Date Mfgr Received | 2014-09-29 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-07-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT INSULIN |
| Generic Name | INSULIN |
| Product Code | CFP |
| Date Received | 2014-06-17 |
| Catalog Number | 08K41-26 |
| Lot Number | 37020LP55 |
| Device Expiration Date | 2014-12-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-17 |