MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PURE SAMPLE SUPPLY UNIT

Catalog Number 09031537001

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable mg2 magnesium gen.2 results from two patient samples tested on the cobas pure sample supply unit.The reporter stated that they noted occasional spikes in qc results which were resolved on rerun.The reporter stated that they have been repeating elevated mg results for a week.The reporter was able to provide one patient sample with discrepant results: the initial result was 1.22 mmol/l.The first repeat result was 0.898 mmol/l.The second repeat result was 0.899 mmol/l.The third repeat result was 0.894 mmol/l.The fourth repeat result was 0.898 mmol/l.

Manufacturer Narrative

The reagent lot number and the expiration date were requested but not provided.The patient sample was hemolyzed (3+) and a hemolysis/icterus/lipemia (hil) index of 523/0/77.The investigation is ongoing.

Manufacturer Narrative

The investigation excluded reagent issues.The customer implemented an additional extra wash cycle (ewc).The analyzer was confirmed to be performing within specifications.Product labeling states "carryover - take adequate measures (for example, extra wash cycles) to avoid extra testing and potentially incorrect results." the investigation determined the customer's actions resolved the issue.The cause of the event could not be determined.

• Brand Name: COBAS PURE SAMPLE SUPPLY UNIT
• Type of Device: SAMPLE SUPPLY UNIT
• 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
• MDR Report Key: 17817572
• MDR Text Key: 324255483
• Report Number: 1823260-2023-03110
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K220134
• 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: 11/06/2023

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: 09031537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 11/06/2023
• 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