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

Catalog Number 04912551190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable d-dimer gen.2 results for one patient from cobas 8000 cobas c 502 module serial number (b)(4).The initial result was 10.29 ug/ml with a data flag.The result with an automatic dilution was 10.25 ug/ml.On (b)(6) 2018, the customer performed a manual 1:10 dilution and the results were 0.03 ug/ml and 0.05 ug/ml.The sample was retested with no dilution and the result was 10.83 ug/ml.A new sample was collected and the result was 10.38 ug/ml with a data flag and with an automatic dilution, the result was 10.83 ug/ml.With a manual 1:6 dilution, the result was 0.96 ug/ml.The result from a "bcs" analyzer was 197 ng/ml and from an architect analyzer was 132.49 ng/ml.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The field service representative performed a precision check and confirmed the instrument was working according specification.

Manufacturer Narrative

The customer provided a sample for investigation.The investigation concluded the undiluted results were higher than the diluted results.The low diluted results compared to the higher undiluted results is consistent with a non-specific agglutination, which leads to falsely high results.Based on the calibration and qc data, a general reagent issue can be excluded.The provided alarm trace contains multiple abnormal sample aspiration alarms, and abnormal sample probe movement alarms on the day of the event.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7991355
• MDR Text Key: 125925153
• Report Number: 1823260-2018-03779
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K062203
• 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
• Report Date: 12/10/2018

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: 04912551190
• Device Lot Number: 33132901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 10/03/2018; 10/03/2018
• Supplement Dates FDA Received: 11/20/2018; 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR