MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-02-24 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[9964150]
Product evaluation was performed to investigate this issue. The lot search determined that there is no unusual activity for the likely cause lot and the trend review determined that complaint activity was not atypical for the issue under investigation. Additionally, accuracy testing was completed using likely cause lot 09020lp36 and four panels with known concentrations of insulin. All panels were within the respective acceptance ranges. Based on the results of this investigation, the architect insulin reagent lot 09020lp30 is performing as intended and no additional product issues were identified. No deficiency was identified related to the alleged malfunction reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
[9968414]
Correction was added (product lot number was corrected from 09020lp30 to 09020lp36).
Patient Sequence No: 1, Text Type: N, H10
[18803378]
This report is being submitted to reference a previous report (3002809144-2012-00026) which was previously submitted under the incorrect manufacturer site. (b)(4). Product evaluation is in process and the results wil be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[18975076]
The customer stated that one patient sample generated a falsely elevated result for the architect insulin assay. A result of 119. 2 uu/ml was repeated at 10. 34 uu/ml using a different (non-abbott) method. The patient was monitored and had a history of insulin results around 10 uu/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2012-00045 |
| MDR Report Key | 2468015 |
| Report Source | 01 |
| Date Received | 2012-02-24 |
| Date of Report | 2012-01-29 |
| Date Mfgr Received | 2012-04-27 |
| Date Added to Maude | 2012-08-23 |
| 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 | 0 |
| 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 | 847937-512 |
| 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 |
| Product Code | CFP |
| Date Received | 2012-02-24 |
| Catalog Number | 08K41-26 |
| Lot Number | 09020LP36 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-02-24 |