MAUDE Adverse Event Report: PRIMUS CORPORATION PREMIER HB9210 HBA1C CONTROL KIT; HBA1C ASSAY

Model Number 01-04-0020

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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.

• Brand Name: PREMIER HB9210 HBA1C CONTROL KIT
• Type of Device: HBA1C ASSAY
• Manufacturer (Section D): PRIMUS CORPORATION; 4231 e 75th terrace; kansas city MO 64132
• Manufacturer (Section G): PRIMUS CORPORATION; 4231 e 75th terrace; kansas city MO 64132
• Manufacturer Contact: josh wears ; 4231 e 75th terrace; kansas city, MO 64132 ; 7164837427
• MDR Report Key: 12819907
• MDR Text Key: 282332512
• Report Number: 1931251-2021-00001
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 05391516748087
• UDI-Public: 05391516748087
• Combination Product (y/n): N
• PMA/PMN Number: K112015
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 01-04-0020
• Device Catalogue Number: 01-04-0020
• Device Lot Number: 12160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other