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 2016-06-20 for ARCHITECT INSULIN 08K41-27 manufactured by Abbott Laboratories.
[47794959]
(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
[47794960]
The customer observed falsely elevated architect insulin assay results for 3 patients. The customer provided the following data. The retest results were generated at another laboratory, test method/ platform is unknown): sample 1: initial 27 retest 14; sample 2: initial 30 retest 17; sample 3 initial 38 retest 9. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[48520797]
On (b)(6) 2016 the suspect medical device lot number was updated. This is documented. Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, a batch record review and a review of labeling. Return material was not available from the customer. An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably. Tracking and trending did not identify an adverse trend for the lot in question. No issues were identified which would indicate a product deficiency from the batch record review. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency and no malfunction of the architect insulin reagent, list (b)(4), lot 60121lp76, was identified.
Patient Sequence No: 1, Text Type: N, H10
[75936185]
Correction to the evaluation summary previously documented. The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the documentation of no malfunction is inaccurate. However, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00068 |
| MDR Report Key | 5736198 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-06-20 |
| Date of Report | 2017-05-11 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-06-20 |
| 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 | 2016-06-20 |
| Catalog Number | 08K41-27 |
| Lot Number | 60151LP76 |
| Device Expiration Date | 2016-10-21 |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-20 |