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 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received a questionable low roche cardiac d-dimer result from cobas h232 meter serial (b)(4).The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.At 10.50, the result from the cobas h232 was 0.28.At 21.15, the result from a sysmex cs2100 analyzer was 0.66.No unit of measure was provided.The doctor stated he expected a difference in the results over the time frame, but not to this extent.There was no allegation of an adverse event.

Manufacturer Narrative

The customer meter was received for investigation and was tested with relevant retention material of roche cardiac d-dimer of lot 26452210 along with a qualified cobas h232.One native blood sample and two spiked blood samples (c=approx.0.7 ¿g/ml), were used in comparison with the master lot #17339780.Results: cobas h232 from the customer with strip lot # 26452210: native blood sample: 0.32 ¿g/ml.First spiked blood sample (c=approx.0.7 ¿g/ml): 0.72 ¿g/ml.Second spiked blood sample (c=approx.0.7 ¿g/ml): 0.79 ¿g/ml.Qualified cobas h232 with master lot strips: native blood sample: 0.31 ¿g/ml.First spiked blood sample (c=approx.0.7 ¿g/ml): 0.71 ¿g/ml.Second spiked blood sample (c=approx.0.7 ¿g/ml): 0.77 ¿g/ml.All of the results fulfilled the requirements.No device problem was found.

• 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: 7651821
• MDR Text Key: 113186747
• Report Number: 1823260-2018-02151
• 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: 07/17/2018

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: 26452211
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1