MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-08-11 for ARCHITECT INSULIN 08K41-26 manufactured by Abbott Laboratories.
[51938007]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient identifier whole sid (b)(6). An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[51938008]
The customer observed falsely elevated insulin patient results generated using the architect insulin reagents. The following data was provided (uu/ml). Sid (b)(6) result 72. 80. Previous results for the patient were provided, 27. 4, 34. 7. Dilution linearity testing results ranged from 21. 60 to 28. 80. The patient is an (b)(6) weighing less than (b)(6). The mother of the (b)(6) is a diabetic patient. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[54058826]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of field data, a review of labeling, and accuracy testing. No adverse trend was identified for the customer's issue. Review of field data found the complaint lot performance was comparable to other lots, and no issue was found. Labeling was reviewed and found to be adequate. Device history review did not identify any issues that may have caused the customer issue. The product was not available for return. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[75540117]
The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended. However, no systematic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00082 |
| MDR Report Key | 5869475 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-08-11 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2016-08-11 |
| 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 | 3 |
| Event Location | 3 |
| 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 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| 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 | 2016-08-11 |
| Catalog Number | 08K41-26 |
| Lot Number | 61020LP77 |
| Device Expiration Date | 2016-11-17 |
| Operator | HEALTH PROFESSIONAL |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-11 |