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

Catalog Number	08463662001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable gluc3 glucose hk gen.3 result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was not reported outside of the laboratory.The initial result was accompanied by a data flag in their laboratory information system (lis) and was deemed a critically low result that did not match the clinical picture of the patient, prompting the rerun of the patient sample.The initial result was 3.92 mg/dl.The repeat result was 174 mg/dl.The repeat result was deemed correct. .
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d.Device identification and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) inspected the rinse levels for cuvettes, probe washing, rinse nozzles, vacuum, and gear pump pressure, and checked for other issues; no issues were noted.He verified the analyzer's performance by a 21-cup precision test with successful results.The investigation reviewed the last calibration performed on 20-oct-2023; the results were within specifications.The investigation reviewed the qc data; the qc was within -2 standard deviations (sd).There was no indication of a performance issue of the reagent.The investigation reviewed the alarm trace; there were multiple "sample short", "sample clot detection", and "sample foam detection" alarms noted on the date of the event, close to the time the patient sample was processed.This is an indication of possible poor sample quality.After the service visit, no further issues were reported by the customer.The investigation determined the service actions verified the module's performance.The cause of the event could not be determined.

• 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: 18463068
• Report Number: 1823260-2024-00066
• Device Sequence Number: 7116988
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191899
• 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): 02/08/2024
• 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 Catalogue Number: 08463662001
• Device Lot Number: 734489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/08/2024
• 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: CALCIUM CHLORIDE; EPINEPHRINE; FENTYNOL; INSULIN; LOHEXOL; MIDACOLAM; SODIUM CHLORIDE
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 112 KG