MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HEMOGLOBIN A1CDX GEN. 3; GLYCOSYLATED HEMOGLOBIN ASSAY

Catalog Number 08056668190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas c 303 analyzer is (b)(6).The sample tube appeared under-filled.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with tina-quant hemoglobin a1cdx gen.3 on a cobas pure c 303 analytical unit.The sample initially resulted in an hba1c value of 7.91 % and it repeated as 5.44 %.

Manufacturer Narrative

The customer confirmed that the 5.44 % value was the one that was expected for the patient.The provided quality control data showed some results that were outside of range.The sample tube was underfilled.The investigation determined that a reagent issue is not likely.The field service engineer checked and adjusted the rinsing assembly and cleaned a probe.A hardware performance check was acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
• Type of Device: GLYCOSYLATED HEMOGLOBIN ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18720114
• MDR Text Key: 336639753
• Report Number: 1823260-2024-00457
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): Y
• Reporter Country Code: TC
• PMA/PMN Number: K072714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08056668190
• Device Lot Number: 708820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1