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

Catalog Number 09031537001

Device Problem High Test Results (2457)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the ca2 (calcium gen.2) assay on a cobas pure sample supply unit.The sample initially resulted in a ca2 value of 2.98 mmol/l and repeated as 2.35 mmol/l.The initial questionable result was reported outside of the laboratory.The ca2 reagent lot was 705711 with an expiration date of 31-may-2024.

Manufacturer Narrative

The field service engineer changed the sample probe and performed adjustments on the sample and reagent probes.The washing water amount was checked.The issue did not re-occur.The investigation is ongoing.

Manufacturer Narrative

The investigation determined the issue was resolved by the service actions.The issue is consistent with a reagent carryover issue.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16876036
• MDR Text Key: 314930483
• Report Number: 1823260-2023-01517
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/26/2023

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: 04/19/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/26/2023
• 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