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

Catalog Number	05860636001
Medical Device Problem Codes	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	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable na electrode, k, and cl results for 1 sample, questionable na electrode, k results for 1 sample, and questionable na electrode results for 4 samples on a cobas 6000 c 501 module.Sample 1: (b)(6).The initial na result was 124 mmol/l and the repeated result was 138 mmol/l.The initial k result was 3.90 mmol/l and the repeated result was 4.45 mmol/l.The initial cl result was 88.6 mmol/l and the repeated result was 98.4 mmol/l.Sample 2: (b)(6).The initial na result was 123 mmol/l and the repeated result was 137 mmol/l.The initial k result was 3.86 mmol/l and the repeated result was 4.28 mmol/l.Sample 3: (b)(6).The initial na result was 130 mmol/l and the repeated result was 140 mmol/l.Sample 4: (b)(6).The initial na result was 133 mmol/l.And the repeated result was 142 mmol/l.Sample 5: (b)(6).The initial na result was 128 mmol/l and the repeated result was 135 mmol/l.Sample 6: (b)(6).The initial na result was 130 mmol/l and the repeated result was 138 mmol/l.The repeated results were obtained using an alternate instrument and they were believed to be correct.The results were reported outside of the laboratory.The samples were repeated because the results were questioned by the physician.This medwatch will apply to the cl electrode.Please refer to the medwatch with a1.Patient identifier (b)(6).For information related to the na electrode and medwatch with a1.Patient identifier (b)(6).For information related to the k electrode.
Additional Manufacturer Narrative
Section d1-d4, g1, and g4 were updated.The field service representative found a broken internal standard (is) bath and is bath solenoids which was not allowing aspiration of vacuum fangs.He replaced the is bath, is bath solenoids, and tubing to the vacuum pump.Once parts were changed he checked the instrument and performed an air purge and reagent primes.He verified the correct aspiration of the fangs, and performed ise checks.The customer performed calibration, qc, comparison checks, and precision checks.The customer's qc results were ok.There was no indication of a reagent issue.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: 18670752
• Report Number: 1823260-2024-00378
• Device Sequence Number: 17937370
• Product Code: JJE
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024
• 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: 05860636001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/07/2024
• 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
• Patient Sex: Unknown