MalfunctionLCP
PREMIER HB9210 HBA1C CONTROL KIT
Received Nov 16, 2021
Report 1931251-2021-00001 · MDR key 12819907
Device
Generic name
Hba1c Assay
Manufacturer
Primus CorporationModel number
01-04-0020Catalog number
01-04-0020
Lot number
12160
Product problems
- Unable to Obtain Readings
- Unable to Obtain Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HBA1C CONTROL I OF LOT 12160 OBSERVED WITH VALUES ABOVE THE ACCEPTABLE TARGET RANGE. VENDOR IDENTIFIED AN UNCOMMONLY HIGH GLUCOSE LEVEL IN THE CONTROL MATERIAL WHICH GLYCATES OVER TIME CREATED FALSE HIGH VALUES. PRODUCT LOT HAD BEEN PLACED ON SHIPPING HOLD NEAR THE SAME TIME AS THE COMPLAINT. NO KNOWN REPORTING TO MEDICAL STAFF OR PATIENTS.
Remedial action
- Replace