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 08/25/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with tina-quant hbalc gen.3 on a cobas 8000 cobas c 502 module.The first sample initially resulted in an hba1c value of 10 %.The result was not compatible with the patient's previous results and the glucose concentration, so the sample was repeated.The repeat hba1c value was 4.9 %.The second sample initially resulted in an hba1c value of 8 % on 28-aug-2023.The customer did not have any previous results from the patient and the glucose concentration of the sample did not justify the initial value, so the sample was repeated.The repeat hba1c value was 5 %.The third sample initially resulted in an hba1c value of 6.85 % on 30-aug-2023.The customer did not have any previous results from the patient and the glucose concentration of the sample did not justify the initial value, so the sample was repeated.The sample was repeated twice, resulting in hba1c values of 5.65 % and 5.70 %.After the third sample was tested, the field service engineer detected drops on the top of the cuvettes.The rinse unit was cleaned and adjusted.The photometer was checked.Precision studies were performed and were ok.After the service actions, the fourth sample initially resulted in an hba1c value of 11.6 % on 02-sep-2023.The repeat hba1c value was 6.05 %.The repeat value was expected according to the patient's history.

Manufacturer Narrative

The serial number of the c 502 analyzer is (b)(6).The field service engineer replaced the sample probes and no further issues have occurred since this action was performed.The investigation is ongoing.

Manufacturer Narrative

The field service engineer found two tubes of the rinse unit were broken and this was resolved.Precision studies were within specifications.The investigation determined the service actions resolved the issue.

Manufacturer Narrative

Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17765894
• MDR Text Key: 323644088
• Report Number: 1823260-2023-03007
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: K100853NA
• 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,Followup
• Report Date: 11/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 71851601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• 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