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

Catalog Number 08445699190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable results for 1 patient sample tested with a1cx3 assay on a cobas pro c 503 analytical unit serial number (b)(4).The following results were reported: initial result: 10.8%, repeated result: 9.5%.The results were reported outside of the laboratory.The repeated result of 9.5% deemed to be correct.

Manufacturer Narrative

The field service engineer found that a1c qc was out of range.The customer replaced the calibrator with a new lot.Qc was performed and it was within the normal range.

Manufacturer Narrative

The device code was updated.The investigation determined the customer's actions (replacing the reagent pack and forcing a new lot calibration) 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16681835
• MDR Text Key: 312772644
• Report Number: 1823260-2023-01096
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08445699190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• 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