MAUDE Adverse Event Report: ROCHE DIAGNOSTICS C8100 TYPE ALPHA; AUTOMATED SAMPLE PROCESSING UNIT

Model Number C8100

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

The initial reporter stated that three samples were not centrifuged on a cobas 8100 model alpha with crw.The issue occurred intermittently.The customer stated they received questionable potassium results for one patient sample that was processed on the system.The sample was processed on the cobas 8100 model alpha with crw and then tested on a c8000 ise (serial number (b)(4)), resulting in a potassium value of 6.8 mmol/l.The sample was repeated, resulting in a value of 5.5 mmol/l.The questionable result was reported outside of the laboratory.The k electrode lot number and expiration date were not provided.

Manufacturer Narrative

The cause of the event could not be determined from the available data.

• Brand Name: C8100 TYPE ALPHA
• Type of Device: AUTOMATED SAMPLE PROCESSING UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15363888
• MDR Text Key: 305144625
• Report Number: 1823260-2022-02738
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/20/2022

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 Model Number: C8100
• Device Catalogue Number: 07439822001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/20/2022
• 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