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 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of discrepant results for 1 patient sample tested for roche cardiac d-dimer between two h232 instruments.The initial d-dimer result from a venous sample on h232 instrument serial number (b)(4) was 0.6 (unit of measure not provided)."almost simultaneously," the sample was repeated on a second h232 instrument and the result was 1.5.The internal qc failed on h232 instrument with serial number (b)(4) so the customer thinks the result of 0.6 is incorrect.The internal qc for the second h232 instrument passed.The patient was not adversely affected.The cobas h232 instrument nor a similar device is approved for distribution in the united states.The instrument and test strips were requested for investigation.

Manufacturer Narrative

The customer did not return the meter or the test strips.As no product was returned, the investigation could not be completed.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

Relevant retention material roche cardiac d-dimer of lot 25712710 was measured on a cobas h232 at the investigation site with: two native blood samples and two spiked blood samples (c=0.60 g/ml and c=1.5 g/ml), each blood sample n=three test strips.Mean of the measurements on the cobas h232 at the investigation site: first native blood sample: 0.31 g/ml.Second native blood sample: 0.16 g/ml.First spiked blood sample (c=0.60 g/ml): 0.55 g/ml.Second spiked blood sample (c=1.5 g/ml): 1.30 g/ml.The results of all the measurements 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: 7429223
• MDR Text Key: 106039615
• Report Number: 1823260-2018-01152
• 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
• Report Date: 05/23/2018

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 Catalogue Number: 04877802190
• Device Lot Number: 25712711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 04/02/2018; 04/02/2018
• Supplement Dates FDA Received: 05/01/2018; 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1