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

Catalog Number 08056668190

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

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable results for 20 patients' samples tested with the hba1c assay on cobas pro 1 c503 analytical unit serial number (b)(4) compared to pro 2 serial number (b)(4).On (b)(6) 2023 the customer ran the patients' samples on cobas pro 1.On (b)(6) 2023 the patients' samples were rerun on cobas pro 2.Then later that day the customer changed the probe and reran the patients' samples on cobas pro 1.Refer to the attached patients' data.The results were reported outside the laboratory and the customer is in the process of correcting them after they got repeated.The repeat results deemed to be correct.The customer stated that cobas pro 1 was calibrated on 9-feb-2023 but when they loaded a new pack, the calibration reverted to the lot calibration performed on 27-jan-2023.The customer also stated that they noticed a lot of build up on the sample probe.

Manufacturer Narrative

The field service engineer (fse) replaced the probe and calibrated the assay.Calibration and qc were performed and they were within ranges.The fse then ran the samples and they tested well compared to cobas pro2.

Manufacturer Narrative

The customer alleged a new event occured on 2-mar-23 and the qc was out of range.The field service engineer (fse) visited the site again and found that the customer had a bad lot calibration.The fse stated that the customer replaced the reagent pack forcing a new lot calibration.Calibration and qc were performed and they were acceptable.The action of 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: 16581701
• MDR Text Key: 312213800
• Report Number: 1823260-2023-00908
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 08056668190
• Device Lot Number: 64510501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• 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
• Patient Sex: Female