MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-11-23 for ARCHITECT INSULIN 8K41-27 manufactured by Abbott Laboratories.
[1811350]
The customer stated that one patient sample generated a result of 420 mu/l for the architect insulin assay. The same patient sample generated results between 200 mu/l and 250 mu/l a week later. The same patient sample generated a lower result of around 19 mu/l when tested on a non-abbott method. The customer mentioned that the patient had received a dose of synthetic insulin before the sample was tested and believed that the architect analyzer can read synthetic insulin concentrations while the other non-abbott method cannot.
Patient Sequence No: 1, Text Type: D, B5
[8942753]
(b)(4). An investigation was conducted to evaluate this issue. A review for other customer complaints was performed and did not identify any problems related to this assay up to date. Additional testing was performed for the lot in question. The testing completed was identical to the testing performed prior to the reagent kit being released for sale which means the lot meets acceptance criteria. An article called (performance evaluation and cross-reactivity from insulin analogs with the architect insulin assay) was reviewed. The study looked at several insulin analogs and liprolog, a drug prescribed to the patient of this complaint contains the analog lispro which was found to cross-reactive with the assay. Based on the investigation results, no malfunction or product deficiency were identified related to this assay which is meeting its safety, effectiveness and label claims. However; the customer was advised to include the identity of the insulin assay when reporting out results. The customer was also referred to the assay package insert which instructed the user to not use results obtained with different assay methods interchangeable. The customer was also instructed to confirm baseline values for patients being serially monitored.
Patient Sequence No: 1, Text Type: N, H10
[8975253]
(b)(4). An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[17749454]
(b)(4). Additional information was received on (b)(6) 2010 indicated that the patient received two types of insulin analogs (liprolog and levimir). Liprolog is an insulin lispro which is listed in the trouble shooting guide for its ability to cross-react with the assay. Information was received (catalog number) the causative agent shipped to the customer had a list number of 8k41-27 rather than 8k41-25. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00540 |
| MDR Report Key | 1906369 |
| Report Source | 01 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-11-04 |
| Date Mfgr Received | 2010-12-30 |
| Device Manufacturer Date | 2010-07-23 |
| Date Added to Maude | 2011-10-19 |
| 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 KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| 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 | FOR THE DETERMINATION OF HUMAN INSULIN IN SERUM OR PLASMA |
| Product Code | CFP |
| Date Received | 2010-11-23 |
| Catalog Number | 8K41-27 |
| Device Expiration Date | 2011-07-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-11-23 |