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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of questionable roche cardiac d-dimer results for 1 patient from a cobas h 232 meter serial number (b)(4) compared to the laboratory result on the c8000 analyzer.At 21:20 the d-dimer result from the laboratory was positive.The specific result was not provided.The customer stated that results greater than 0.5 ug/ml were considered positive.At 21:27 the initial d-dimer result from the meter was 0.10 ug/ml with a different sample tube.At 23:37 the repeat d-dimer result from the meter was 0.10 ug/ml with the same sample tube used for the initial result.The result from the meter was reported outside of the laboratory.The result from the laboratory was given to the medical professional.There was no allegation of an adverse event.The qc was acceptable.The suspect device was requested to be returned for investigation.

Manufacturer Narrative

The customer did not return their test strips.They did return the meter.Retention material from lot 33295310 was tested on a retention meter and on the customer's returned meter.All test results meet the requirements.

• 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: 8332803
• MDR Text Key: 136004129
• Report Number: 1823260-2019-00574
• 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
• Report Date: 03/15/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 04877802190
• Device Lot Number: 33295310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1