MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08056668190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The a1c reagent lot number is 70882001 and the expiration date is 30-jun-2024.The glucose reagent lot number and expiration date were not provided.The calibration data provided was acceptable.The alarm trace showed two abnormal cell blank alarms.The field service engineer (fse) changed the sample probe.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable a1c-2 tina-quant hemoglobin a1c gen.2 and gluc3 glucose hk gen.3 results for 4 patient samples on a cobas pro c 503 analytical unit.On 04-sep-2023, sample 1 had an initial a1c-2 result of 6.6%.The doctor questioned the result as it did not match the patient's clinical history and the sample was repeated.The sample was repeated twice and the results were 5.39% and 5.49%.The result of 5.49% was deemed correct.On 07-sep-2023, sample 2 had an initial a1c-2 result of 6.31%.The sample was repeated and the result was 5.29%.On 15-sep-2023, sample 3 had an initial glucose result of 30 mg/dl.The repeat result was considered "normal." the exact repeat result was not provided.On 15-sep-2023, sample 4 had an initial glucose result of 22 mg/dl.The repeat result was considered "normal." the exact repeat result was not provided.
Additional Manufacturer Narrative
The qc recovery data provided was acceptable.The field service engineer (fse) changed the heat cut filter and the washing comb teflon coating, performed cell blank measurement, adjusted the photometer and installed a new bulb, and replaced the incubation bath, degasser, and sample probes.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17861833
• Report Number: 1823260-2023-03170
• Device Sequence Number: 5909358
• Product Code: JJE
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): Y
• Initial Reporter Country: PE
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: 08056668190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DIABETES MEDICATION (PATIENT 1)
• Patient Sex: Unknown