MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; FIBRINOGEN AND FIBRIN SPLIT PRODUCTS

Catalog Number 04877802190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of discrepant roche cardiac d-dimer results from two cobas h 232 meters.The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.The d-dimer result was 2.1 ug/ml on h 232 with serial number (b)(4).The d-dimer result was >4.0 ug/ml on h 232 with serial number (b)(4).On (b)(6) 2018 d-dimer result was 0.77 ug/ml on h 232 with serial number (b)(4).The d-dimer result was 1.3 ug/ml on h 232 with serial number (b)(4).There was no allegation of an adverse event.The qc performed on both meters before the measurements were acceptable.

Manufacturer Narrative

The customer did not use any reference method for sample measurement.The measurement was performed at the same time on both meters every time.The meter was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The customer returned h 232 meter with the serial number (b)(4).It was determined the d-dimer results 2.1 ug/ml and 0.77 ug/ml were from h 232 meter (b)(4) , not (b)(4) as previously reported.The investigation is ongoing.

Manufacturer Narrative

The customer material was not returned.Qc passed before the affected samples were run.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The returned h 232 meter was visually investigated.The device was opened and the measuring module was investigated for contamination.During the investigation of the device a dirty mirror was detected.The investigation determined that the contamination and the detected foreign object caused the issue and were caused by improper handling.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7938573
• MDR Text Key: 123959482
• Report Number: 1823260-2018-03433
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2019

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: 04877802190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 09/18/2018; 09/18/2018; 09/18/2018; 09/18/2018
• Supplement Dates FDA Received: 11/30/2018; 12/20/2018; 07/03/2019; 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1