MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for BNP manufactured by Unk.
[63191692]
Bnp reagent, lot 188, failed calibration on the second shipment of this lot and the new lot 189 was sent due to low cal for deviation which was -1. 12050 and the range is from -1. 07-0. 67. Unable to perform assay in lab. Tried now lot and major service (cleaning the luminometer). Manufacturer states regional issue due to rgt lot with no time line to correct issue. Dates of use: (b)(6) 2016. Diagnosis or reason for use: bad reagent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066866 |
| MDR Report Key | 6199332 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-13 |
| Date Added to Maude | 2016-12-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BNP |
| Generic Name | BNP |
| Product Code | NBC |
| Date Received | 2016-12-19 |
| Lot Number | 188 |
| Device Expiration Date | 2017-08-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | BNP |
| Generic Name | BNP |
| Product Code | NBC |
| Date Received | 2016-12-19 |
| Lot Number | 77655189 |
| Device Expiration Date | 2017-08-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-19 |