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

Catalog Number 05336163190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The c502 module serial number was (b)(6).The last preventive maintenance visit was in (b)(6) 2023.The field service engineer (fse) identified broken hoses on the instrument and replaced them.Reagent pipettes, sample pipettes and syringe valves were replaced, instrument check results were within specification.Calibration and qc were acceptable.Repeatability testing was performed with a different analyzer and the results were comparable.The service actions resolved the issue.

Event Description

The initial reporter questioned the results for multiple patient samples tested for tina-quant hba1c gen.3 (hba1c) on a cobas 6000 c (501) module.Discrepant results were provided for 4 patient samples.Patient 1 initial result was 7.6%.The repeat result was 5.5%.On (b)(6) 2023 patient 2 initial result was 11.9%.This result was reported outside of the laboratory where it was questioned as the patient is not a diabetic.On (b)(6) 2023 the repeat result was 4.9%.On (b)(6) 2023 patient 3 initial result was 7.5%.The repeat result was 5.7 %.On (b)(6) 2023 patient 4 initial result was 7.4%.The repeat result was 5.6 %.The questionable results for patients 1, 3 and 4 were not reported outside of the laboratory.

• Brand Name: TINA-QUANT HBALC GEN. 3
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• 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: 17515302
• MDR Text Key: 321087488
• Report Number: 1823260-2023-02607
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K102914
• 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
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05336163190
• Device Lot Number: ACK5P000001LYO9CAC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1