MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CHOLESTEROL GEN. 2; CHOLESTEROL, ENZYMATIC

Catalog Number 08057443190

Device Problem Chemical Problem (2893)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable chol2 cholesterol gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial result was around 40 mg/dl.The repeat result was around 200 mg/dl.The exact results were not provided.

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Field b3 was updated.Clarification on the patient results was provided.On (b)(6) 2023, the initial cholesterol result was 4.13 mg/dl.The repeat result was 213 mg/dl.The calibration and qc recovery data provided was acceptable.The alarm trace showed many abnormal aspiration and sample clot detection alarms.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS INTEGRA CHOLESTEROL GEN. 2
• Type of Device: CHOLESTEROL, ENZYMATIC
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18343785
• MDR Text Key: 330782267
• Report Number: 1823260-2023-04062
• Device Sequence Number: 1
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K031824
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057443190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• 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