MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-03 for ARCHITECT BNP 02P14-10 manufactured by Abbott Laboratories.
[92086100]
This report is being filed on an international product, list number 02p14 that has a similar product distributed in the us, list number 08k28. (b)(4) splash to a technician further investigation of the customer issue included a review of the complaint text, a device history review, a search for similar complaints, and a review of labeling. Return parts were not available. A device history review did not find any issues with the product in question. Tracking and trending did not identify an adverse trend or non-statistical trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the architect bnp assay, list number 02p14 was identified.
Patient Sequence No: 1, Text Type: N, H10
[92086101]
While reattaching the control bottle of the architect bnp assay liquid from the bottle dripped out and splashed into their eyes. The technician flushed their eyes with water and the technician had their eyes examined by an opthalmaologist. No treatment was administered. The technician was not wearing protective glasses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00195 |
| MDR Report Key | 7000401 |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-03 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-11-03 |
| 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 | 0 |
| Brand Name | ARCHITECT BNP |
| Generic Name | B-TYPE NATRIURETIC PEPTIDE |
| Product Code | NBC |
| Date Received | 2017-11-03 |
| Catalog Number | 02P14-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-11-03 |