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

Catalog Number 08056668190

Device Problem High Test Results (2457)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c 503 analyzer is (b)(6).The sample probe assembly was changed and adjusted.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with tina-quant hemoglobin a1cdx gen.3 (hba1c) on a cobas pro c 503 analytical unit.The first sample initially resulted in an hba1c value of 7.81 % and it repeated as 5.45 %.The second sample initially resulted in an hba1c value of 7.34 % and it repeated as 5.77 %.The third sample initially resulted in an hba1c value of 5.95 % and it repeated as 5.40 %.

Manufacturer Narrative

The issue was resolved after the exchange and adjustment of a sample probe.No further issues have occurred.The investigation determined the exchange and adjustment of the probe resolved the issue.

• 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: 18158758
• MDR Text Key: 328383651
• Report Number: 1823260-2023-03646
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (y/n): Y
• Reporter Country Code: GR
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08056668190
• Device Lot Number: 715056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• 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