MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HBA1C III TINA-QUANT HEMOGLOBIN A1C III; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number HBA1C TQ G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with a1c-3 tina-quant hemoglobin a1c gen.3 on a cobas 4000 c (311) stand alone system.The sample resulted with an hba1c value of 4.1 % when tested on the customer's c 311 analyzer and this value was reported outside of the laboratory.The sample was sent to another laboratory for testing with an unknown method, resulting with an hba1c value of 6.2 %.All measurements performed on the c 311 analyzer repeat with the same value initially obtained on the c 311 analyzer.The serial number of the customer's c 311 analyzer is (b)(4).

Manufacturer Narrative

Upon review of the calibration data, frequent sensitivity errors were observed and this is abnormal.This alarm is indicated if the sensitivity value obtained in a calibration falls out of the sensitivity limits specified in the analyzer settings for the test.Upon review of control data, high imprecision was observed.The instrument is not performing as expected.Based on alarm trace information, the customer maintenance is not being performed according to instructions.The sample probe was bent and this was determined to be the root cause of the issue.

• Brand Name: HBA1C III TINA-QUANT HEMOGLOBIN A1C III
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9745665
• MDR Text Key: 220292660
• Report Number: 1823260-2020-00533
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: 38625601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1