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

Catalog Number 04404483190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 1 patient's serum sample tested with sodium (na) test and 1 patient's serum sample tested with na test and glucose hk gen.3 (gluc3) assay on a cobas 6000 c501 analyzer.Sample 1: na: initial result: 165 mmol/l.Repeat result: 140 mmol/l.Sample 2: na: initial result: 150 mmol/l.Repeat result: 141 mmol/l.Gluc3: initial result: 42 mg/dl.Repeat result: 106 mg/dl.The medical personnel questioned the initial results and requested the samples be repeated.The repeat results were deemed to be correct.

Manufacturer Narrative

The na electrode lot number and expiration date were not provided.The gluc3 reagent lot number was 74348401.The expiration date was not provided.The field service engineer found that the rinse vacuum line was ripped at the nozzle.He repaired the vacuum line and inspected the rinse tubing and the rinse levels.The customer performed qc and mechanical checks and they were successful.Precision studies were performed and they were within specifications.The investigation is ongoing.

Manufacturer Narrative

Section d4 was updated.Correction: sample 1 and sample 2 were plasma samples.The glucose calibration was last performed on (b)(6) 2023 and it was acceptable.The sodium calibration was performed on (b)(6) 2024 and it was acceptable.Qc recovery was within the range.No indication of a performance issue with the reagent.The service action (repairing the vacuum line and inspecting the rinse tubing and the rinse levels) resolved the issue.No further issues were reported afterward.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: 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: 18913316
• MDR Text Key: 337772081
• Report Number: 1823260-2024-00772
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 04404483190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1