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

Catalog Number 07559674190

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

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The c513 analyzer serial number is (b)(6).The field service representative (fsr) checked calibration, qc, and operator maintenance and did not identify any issues.Instrument performance testing was acceptable.Frequent abnormal aspiration alarms were observed on the alarm trace data.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant high results for 2 patient samples tested for tina-quant hemoglobin a1cdx gen.3 on a cobas c513 analyzer.Patient 1 initial result was 7.41% on (b)(6) 2023 the sample was repeated on a cobas 8000 c 502 module with a result of 5.86%.Patient 2 initial result was 11.03%.On (b)(6) 2023 the sample was repeated on a cobas 8000 c 502 module with a result of 9.51%.

Manufacturer Narrative

The field service engineer (fse) made reagent and sample probe adjustments.The cuvette segments were seated properly.The sample probe was checked for obstructions by flushing.The fse noted that the reagent packs may have frozen in the customer's refrigerator.The customer has not complained of any further issues.The investigation did 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: 17766033
• MDR Text Key: 323644038
• Report Number: 1823260-2023-03008
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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: 11/03/2023

1 Device was Involved in the Event

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 07559674190
• Device Lot Number: 67251001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• 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