MalfunctionNBC

BNP

Received Dec 19, 2016 · Event occurred Dec 13, 2016

Report MW5066866 · MDR key 6199332

Device

Generic name

Bnp

Manufacturer

Unk

Lot number

188

Product problems

Calibration Problem

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

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.