MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HCV; ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMP.FOR DETECTION OF HEPATITIS C RNA,HCV

Catalog Number 06997732190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output Problem (3005)

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

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.(b)(6).Common device name abbreviated, full name: assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna, hepatitis c virus.

Event Description

A customer from norway alleged discrepant results with the cobas® hcv quantitative nucleic acid test for use on the cobas® 6800/8800 systems.It is unknown how many samples were tested.However, it was alleged that one of the 6800 instruments missed some samples at 50 iu/ml and below to 15 iu/ml.It is unknown if the results were released.No harm alleged.An investigation is being conducted to evaluate the customer issue.

Manufacturer Narrative

Only one run was provided for cobas 6800 (sn (b)(6)) which did not show any major shifts or suppressions in the control curves and the control cts performed consistently.Although requested, data generated on cobas 6800 (sn (b)(6)) was not able to be provided.Based on the analysis performed, there is no indication the product is not performing as intended.Although unknown, the likely cause of the discrepancies alleged is site or sample-specific factors like workflow and handling.B6 updated with sample information.B5 updated with which instrument was alleged.

Event Description

The customer alleged that when running samples on cobas® 6800 (sn 1942), the instrument missed samples at 15 iu/ml to 50 iu/ml.

Event Description

The results were used for verification of the instrument and the results have only been used internally.

Manufacturer Narrative

Updated b6 and b5 regarding the number of samples alleged and the fact that the samples were used for a study and results only used internally.

• Brand Name: COBAS® HCV
• Type of Device: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMP.FOR DETECTION OF HEPATITIS C RNA,HCV
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 15908031
• MDR Text Key: 307902530
• Report Number: 2243471-2022-01009
• Device Sequence Number: 1
• Product Code: MZP
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P150015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 06997732190
• Device Lot Number: H23165
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• 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