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 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable d-dimer results for five patient samples from a cobas h232 meter serial number (b)(4) on (b)(6) 2017 when compared to the results previously obtained from a mini vidas analyzer.The cobas h232 meter is not sold nor is like or similar to a product sold in the united states.It was unclear if the same samples were used for the testing on the different devices.Clarification was requested but was not provided.Sample 1: the result from the mini vidas on (b)(6) 2017 was 198.93 ng/ml.The result from the h232 meter was 180.00 ng/ml.Sample 2: the result from the mini vidas on (b)(6)2017 was 2119.51 ng/ml.The result from the h232 meter was 490.0 ng/ml.Sample 3: the result from the mini vidas on (b)(6) 2017 was 853.30 ng/ml.The result from the h232 meter was 550.00 ng/ml.Sample 4: the result from the mini vidas on (b)(6) 2017 was 1130.25 ng/ml.The result from the h232 meter was 680 ng/ml.Sample 5: the result from the mini vidas on (b)(6) 2017 was 324.98 ng/ml.The result from the h232 meter was 280.0 ng/ml.The erroneous results were not reported outside of the laboratory.The patients were not adversely affected.No customer material was received for investigation.Relevant retention material of roche cardiac d-dimer of lot 19752510 was tested on a qualified cobas h232 with: two native blood samples and two spiked blood samples (c=0.80 ¿g/ml and c=1.10 ¿g/ml), each blood sample was tested with three test strips.The mean of the measurements on a qualified cobas h232: first native blood sample: 0.17 ug/ml.Second native blood sample: 0.29 ug/ml.First spiked blood sample (c=0.80 ¿g/ml): 0.76 ug/ml.Second spiked blood sample (c=1.10 ¿g/ml): 0.99 ug/ml.The results of all measurements fulfill the requirements.

Manufacturer Narrative

A specific root cause could not be identified.Based on the available information, there was no indication of a product problem.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6893088
• MDR Text Key: 89504622
• Report Number: 1823260-2017-02088
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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: 11/01/2017
• Device Catalogue Number: 04877802190
• Device Lot Number: 19752510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1