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

Model Number HBA1C TQ G3

Device Problem Non Reproducible Results (4029)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer changed the reagent and no further issues occurred after this.Calibration data showed frequent calibration errors and short samples.Quality control data showed a value that was outside of range.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.

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 6000 c (501) module.No incorrect results were reported outside of the laboratory.The sample initially resulted in an hba1c value of 8.5 %.The sample was repeated on (b)(6) 2022, resulting in a value of 12.4 %.The repeat value was believed to be correct.The serial number of the c 501 analyzer is (b)(4).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15880427
• MDR Text Key: 307783602
• Report Number: 1823260-2022-03790
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: ASKU
• Device Lot Number: 625162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• 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