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

Catalog Number	08056668190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-00908
• Device Sequence Number: 4925661
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female