MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	CA GEN.2
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Event or Problem Description
We received an allegation of questionable results for approximately 5 patient samples tested for calcium gen.2 (ca2) on a cobas 6000 c (501) module.Discrepant results were provided for 1 patient sample.The initial result was 6.2 mg/dl.The repeat result was 10.3 mg/dl.The sample was repeated as the initial result was critical and inconsistent with the patient¿s previous results.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2024 was ok and there were no alarms.The sample centrifugation time may have been shorter than recommended by the tube manufacturer.The field service engineer found damaged vacuum tubing on the rinse mechanism.The tubing was replaced.Air purges, reagent priming, and mechanism checks were performed.Calibration, controls, and precision studies were performed.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) MODULE
• 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: 20035676
• Report Number: 1823260-2024-02441
• Device Sequence Number: 19601870
• Product Code: JJE
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 09/17/2024

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: 05/31/2025
• Device Model Number: CA GEN.2
• Device Catalogue Number: 05860636001
• Device Lot Number: 783185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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: ALBUTEROL INHALER; ANASTROZOLE; ATORVASTATIN; BD REGULAR BEVEL 22 G NEEDLES; CLOMIPHENE; DICLOFENAC SODIUM; EASY TOUCH LUER LOCK INSULIN SYRINGE; FAMOTIDINE; FLUOCINONIDE; HYDROCORTISONE 1% CREAM; KETOTIFEN OPTHALMIC SOLUTION; MOMETASONE NASAL SPRAY; MONTELUKAST; ONDANSETRON; PILOCARPINE HCL 1.25% DROP; RUXOLITINIB; SAFETY NEEDLES; SILDENAFIL; TESTOSTERONE CYPIONATE INJECTION; TIRZEPATIDE PREFILLED PEN
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 131 KG