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 Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

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 tested for roche cardiac d-dimer on a cobas h232 instrument with serial number (b)(4).The d-dimer result from the h232 instrument was 0.59 ug/ml.The d-dimer result from the laboratory using the sysmex cs-5100 method was 1.3 ug/ml.The sample for the h232 instrument was in a lithium heparin tube and the sample for the laboratory was in a citrate tube.The samples were taken at "roughly the same time"; the lab sample was analyzed 4-6 hours later.The customer stated they had similar discrepant results for 4 other patients over the course of 1 month.The customer was not able to provide any specific results for these patients.There was no allegation that an adverse event occurred.The meter and test strips were requested for investigation.Neither the h232 instrument nor a similar device is sold in the united states.Relevant retention material roche cardiac d-dimer of lot 26452210 was measured on a cobas h232 at the investigation site with two native blood samples and two spiked blood samples (c=0.65 ¿g/ml and c=1.4 ¿g/ml); each blood sample n=three test strips.The mean of the measurements on the cobas h232 at the investigation site: first native blood sample: 0.22 ¿g/ml, second native blood sample: 0.37 ¿g/ml, first spiked blood sample (c=0.65 ¿g/ml): 0.59 ¿g/ml, second spiked blood sample (c=1.4 ¿g/ml): 1.20 ¿g/ml.The results of all the measurements meet the requirements.

Manufacturer Narrative

The customer returned the meter and the test strips involved in the event.Relevant retention material roche cardiac d-dimer of lot 27654210 was measured on the cobas h232 from the customer and 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=1.4 ¿g/ml); each blood sample n=two test strips on cobas h232 from the customer and n=three test strips on the cobas h232 at the investigation site.Mean of the measurements on cobas h232 from the customer: first native blood sample: 0.23 ¿g/ml.Second native blood sample: 0.17 ¿g/ml.First spiked blood sample (c=0.60 ¿g/ml): 0.62 ¿g/ml.Second spiked blood sample (c=1.4 ¿g/ml): 1.20 ¿g/ml.Mean of the measurements on the cobas h232 at the investigation site: first native blood sample: 0.22 ¿g/ml.Second native blood sample: 0.20 ¿g/ml.First spiked blood sample (c=0.60 ¿g/ml): 0.61 ¿g/ml.Second spiked blood sample (c=1.4 ¿g/ml): 1.20 ¿g/ml.Test strip from the customer was measured on cobas h232 from the customer with the first spiked blood sample (c=0.60 ¿g/ml): result: 0.63 ¿g/ml.The results of all measurements meet the requirements.The cobas h232 from the customer showed no irregularities.The investigation was unable to find a definitive root cause for the event.

• 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: 7446205
• MDR Text Key: 106907720
• Report Number: 1823260-2018-01230
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 27654210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1