MAUDE Adverse Event Report: ROCHE DIAGNOSTICS C.F.A.S. HBA1C; CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT

Model Number	C501
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received questionable results for 77 patient samples tested with a1c-3 tina-quant hemoglobin a1c gen.3 on a cobas 6000 c (501) module.An example was provided for one patient sample that had discrepant hba1c results.The customer noted that the hba1c calibration performed on (b)(6) 2022 had a large jump in signal values.The reagent pack was then removed on (b)(6) 2022.The sample initially resulted in an hba1c value of 10.7 % on (b)(6) 2022 and this value was reported outside of the laboratory.A physician questioned the result.The sample was repeated, resulting in a value of 6.9 %.The repeat value was deemed correct.The hba1c reagent lot number was 62959801, with an expiration date of 31-dec-2023.
Additional Manufacturer Narrative
The last calibrations performed on 01-nov-2022 and 02-nov-2022 were ok and there were no alarms.Quality controls were outside of range initially on 01-nov-2022 and recovered within range afterward.There was no indication of a reagent performance issue.Upon review of the alarm trace, an abnormal aspiration alarm occurred on 02-nov-2022.Multiple sample short alarms occurred on 05-nov-2022 and this can indicate poor sample quality.A calibration alarm and an hba1c sample cup type error also occurred on 05-nov-2022.The field service engineer determined the calibrator material was incorrectly reconstituted.The customer used 1 ml.Of water instead of 2 ml.To reconstitute the calibrator material.Controls were outside of range.A new calibration was performed with properly prepared material.Controls were within range and the patient samples were repeated after this.The investigation determined the service actions resolved the issue.

• Brand Name: C.F.A.S. HBA1C
• Common Device Name: CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT
• 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: 15857140
• Report Number: 1823260-2022-03763
• Device Sequence Number: 5216621
• Product Code: KRZ
• UDI-Device Identifier: 04015630921096
• UDI-Public: 04015630921096
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052101
• 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): 12/14/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: C501
• Device Catalogue Number: 04528417190
• Device Lot Number: ASKU
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ATORVASTATIN; HYDROCHLOROTHIAZIDE; KCL; LEVOTHYROXINE; METFORMIN; OMEPRAZOLE
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 64 KG