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

Catalog Number 05336163190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 c 501 module serial number was requested but not informed.The investigation is ongoing.

Event Description

The initial reporter questioned the calculation results from one patient tested for hba1c (tina-quant hbalc gen.3) assay on a cobas 6000 c 501 module.The initial hba1c measurement was 51.90 mmol/mol.The result calculated by cobas 6000 and transferred to the lis was 7.6%.The result calculated manually with the % dcct/ngsp formula (%hba1c = (hba1c/hb) + 91,5 +2,15) was 6.9%.The results were reported outside of the laboratory and questioned by the physician.

Manufacturer Narrative

The c501 module serial number was (b)(6).The ratio definition for mmol/mol hba1c and % hba1c calculation is as follows: protocol 1 (mmol/mol hba1c acc.To ifcc): abbreviated ratio name rwi3.Equation(a1-w3/hb-w3) × 1000 - unit mmol/mol.The mmol/mol hba1c values according to protocol 1 (ifcc) must be manually calculated according to the above equation.A calculated test with the formula in protocol 1 can be programmed on the instrument.The ratio for hba1c (mmol/mol hba1c acc.To ifcc and % hba1c acc.To dcct/ngsp) will be automatically calculated after the result output of both tests.Protocol 2 (% hba1c acc.To dcct/ngsp): abbreviated ratio name rwd3 (891) equation(a1-w3/hbw3) × 91.5 + 2.15 - unit %.Protocol 2 is already implemented in when using application acn 891 of the assay.The customer declined to provide any additional information for the investigation.There is no indication of a general product problem and there is no information to suggest there are any general issues with the way the hba1c test on the c501 module calculates the results.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 17515295
• MDR Text Key: 321082894
• Report Number: 1823260-2023-02606
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/01/2023

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• 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