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

Model Number	01-04-0020
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 1931251-2021-00001
• Device Sequence Number: 17340334
• Product Code: LCP
• UDI-Device Identifier: 05391516748087
• UDI-Public: 05391516748087
• Combination Product (Y/N): N
• PMA/510(K) Number: K112015
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown