MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 04745914001

Device Problem High Readings (2459)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 c501 module serial number was (b)(6).The field service engineer found the ultrasonic mixer was misadjusted, there were issues with the gear pump head and with the sample probe.The investigation is ongoing.

Event Description

There was an allegation of questionable hemoglobin a1c results from the cobas 6000 c501 module.Patient 1 initial result was 10.4%.The repeat result after recalibration was 7.50%.Patient 2 initial result was 10.65%.The repeat result after recalibration was 7.88%.Patient 3 initial result was 10.34%.The repeat result after recalibration was 7.69%.Patient 4 initial result was 8.20%.The repeat result after recalibration was 6.14%.Patient 5 initial result was 8.27%.The repeat result after recalibration was 6.26%.

Manufacturer Narrative

The investigation did not identify the cause of the event.The event was consistent with insufficient maintenance.Medwatch fields d1-d4, g1, and g4 were updated.

• Brand Name: COBAS 6000 C501 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: 18265552
• MDR Text Key: 329717363
• Report Number: 1823260-2023-03851
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745914001
• Device Lot Number: 71851601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1