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

Catalog Number	05860636001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable na electrode results for 2 patient samples on a cobas 6000 c (501) module.Patient 1: (id: (b)(6): the initial result was 177 mmol/l.The repeated result was 135 mmol/l.Patient 2: (id: (b)(6): the initial result was 167 mmol/l.The repeated result was 138 mmol/l.The questionable results were reported outside the laboratory and corrected reports were filed.The samples were repeated due to failing delta checks and the initial result for patient 1 did not match the patient's clinical history.The repeated results were obtained on another analyzer and were believed to be correct.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Sections d1-d4, g1, and g4 were updated.The field service representative found the rinse tubing was cracked.The rinse tubing was adjusted to resolve the leak.After service, no issues were reported by the customer.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: 20260712
• Report Number: 1823260-2024-02710
• Device Sequence Number: 7545817
• Product Code: JJE
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 11/08/2024

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 Catalogue Number: 05860636001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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: PATIENT 1: ALBUTEROL; PATIENT 1: ASPIRIN; PATIENT 1: BRISDOL; PATIENT 1: CARVETILOL; PATIENT 1: DEXTROSE AND GLUCOSE; PATIENT 1: FLOMAX; PATIENT 1: HYDROCORTISONE; PATIENT 1: KETOROLAC; PATIENT 1: LEVANOX; PATIENT 1: LEVOTHYROXINE; PATIENT 1: LORAZEPAM; PATIENT 1: MAGNESIUM SULFATE; PATIENT 1: MENTHOL ZINC OXIDE TOPICAL OINTMENT; PATIENT 1: NORFLEX INJECTABLE; PATIENT 1: PEPSID; PATIENT 1: PLAVIX; PATIENT 1: POTASSIUM CHLORIDE; PATIENT 1: POTASSIUM PHOSPHATE/SODIUM PHOSPHATE; PATIENT 1: SODIUM CHLORIDE; PATIENT 1: SUROSEMIDE; PATIENT 2: BENADRYL INJECTION; PATIENT 2: LABETALOL; PATIENT 2: NORMAL SALINE 1000ML INFUSION; PATIENT 2: PROCHLORTERAZINE INJECTION
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 69 KG