MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-28 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[4245117]
The customer stated that the architect analyzer generated falsely elevated insulin results on one patient sample. Sid (b)(6) initial insulin on (b)(6) 2014 = >300uu/ml / 1:2 dilution result = >600uu/ml. The patient sample was sent out and the lumipulse result = 2. 0uu/ml. There was no additional patient information provided. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[11597816]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[11819289]
Further evaluation of the customer issue included a review of the complaint text, a review for similar complaints, accuracy testing, and a review of labeling. The customer reported falsely elevated insulin results. A review of complaints did not identify any issues for falsely elevated insulin results for lot 33020lp52. Accuracy testing was completed using retained kits of reagent lot 33020lp52. A deficiency was not identified as the testing showed that lot 33020lp52 performed per specification. The testing showed that acceptance criteria were met, which indicates the product is performing acceptably. No malfunction was identified. A review of labeling determined that the assay values were obtained with different methods, which cannot be used interchangeably, due to differences in assay methods and reagent specificity. No additional issues were identified; no further action is required at this time. Based on the investigation results there is no indication of a product deficiency and the architect insulin reagent is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2014-00077 |
| MDR Report Key | 3708272 |
| Report Source | 01,05 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-02-21 |
| Date Mfgr Received | 2014-05-28 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-03-28 |
| 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 | 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 |
| Generic Name | INSULIN |
| Product Code | CFP |
| Date Received | 2014-03-28 |
| Catalog Number | 08K41-26 |
| Lot Number | 33020LP52 |
| Device Expiration Date | 2014-07-16 |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2014-03-28 |