MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HBA1C III TINA-QUANT HEMOGLOBIN A1C III; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number HBA1C TQ G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The field application specialist ran controls on both the dca analyzer and the first c 501 analyzer.The specialist placed fresh reagent on both the first c 501 analyzer and a second c 501 analyzer (serial number (b)(4)).The test was then calibrated on both c 501 systems using fresh calibrator.Both third party and roche controls were tested and recovered close to the mean.The third patient sample was then repeated on both c 501 systems on (b)(6) 2020, resulting with a value of 12.0 % on the first c 501 analyzer and a value of 12.4 % on the second c 501 system.(b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with a1c-3 tina-quant hemoglobin a1c gen.3 on a cobas 6000 c (501) module.The third patient sample also had a discrepant hba1c result when tested on a second c 501 analyzer.The samples have a negative bias in hba1c values when compared to values measured on a dca advantage analyzer.The first patient sample resulted with an hba1c value of > 14.0 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.3 %.Both analyzer values were reported outside of the laboratory and no corrected reports were issued.The second patient sample, from a (b)(6) male patient born on (b)(6), resulted with an hba1c value of > 14.0 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.2 %.Both analyzer values were reported outside of the laboratory and no corrected reports were issued.On (b)(6) 2020, the reporter ran linearity materials on the dca analyzer and these recovered acceptably.The same linearity materials were tested on the c 501 and failed with negative bias.On (b)(6) 2020, the first sample was repeated on a second dca analyzer, resulting with a value of 11.7 %.On (b)(6) 2020, the second sample was repeated on a second dca analyzer, resulting with a value of 13.2 %.On (b)(6) 2020, the customer checked calibration data for the first c 501 instrument and determined the last hba1c calibration was performed on (b)(6) 2019.The test was then re-calibrated and linearity materials were repeated on this c 501 instrument.On (b)(6) 2020, the first sample was repeated on the first c 501 analyzer, resulting with a value of 11.7 %.On (b)(6) 2020, the second sample was repeated on the first c 501 analyzer, resulting with a value of 11.4 %.The field service engineer checked the first c 501 system on 24-jan-2020 and determined there was an issue with fluidics.The sample probe was replaced.The rinse mechanism was checked and probe volumes were checked.The gear pump pressure and mixers were adjusted.The customer ran controls and these recovered near the mean.After service was performed, the customer ran the linearity materials again on the first c 501 analyzer and linearity failed at the high end of the measuring range.On (b)(6) 2020, the third patient sample from a (b)(6) female patient born on (b)(6), initially resulted with a value of > 14 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.6 %.The serial number of the first c 501 analyzer is (b)(4).

Manufacturer Narrative

The reporter mentioned that on (b)(6) 2020, they had three samples with hba1c results that were higher on the c501.All three resulted with values of >14% accompanied by a data flag on the dca but anywhere between 12.1-12.7 % on the c501.No incorrect results were reported outside of the laboratory.It was asked, but it is not known if the dca and c501 measurements were performed with samples collected from the patient at the same time or if each measurement was performed using a different sample collected from each patient at a different time.Calibration data looked good, however while investigating the issue on 23-jan-2020, the last calibration date was checked and found to be 22-dec-2019.Product labeling states the reagent is stable for 28 days onboard.The assay settings were checked in the instrument and it was found that calibration only occurred when new lots were started.The customer has decided to recalibrate every 2 weeks.Upon review of the alarm trace, sample short alarms, abnormal probe aspiration alarms, and a sample cup type read error occurred on 14-jan-2020.The field service engineer determined there was a fluidics issue with the sample probe.The probe was replaced.The rinse mechanism and probe volumes were checked.The gear pump pressure and mixers were adjusted.The customer ran controls and these recovered near the expected mean.The investigation determined the service actions resolved the issue.

• Brand Name: HBA1C III TINA-QUANT HEMOGLOBIN A1C III
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9705661
• MDR Text Key: 199294701
• Report Number: 1823260-2020-00424
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: 40125801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REFER TO THE ATTACHMENT FOR MEDICATIONS
• Patient Age: 11 YR