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 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned low results for 3 patients tested for roche cardiac d-dimer on an h232 instrument.Based on the data provided, the results for 1 patient were erroneous when compared to a second h232 instrument.The initial cardiac d-dimer result from h232 instrument with serial number (b)(4) was 4.0 ug/ml.Within an hour the same sample was tested on h232 instrument with serial number (b)(4) and the result was 2.4 ug/ml.The result of 4.0 ug/ml is believed to be correct since the customer has received external quality assurance results lower than the acceptable range on the instrument with serial number (b)(4).There was no allegation that an adverse event occurred.Neither the h232 instrument nor a similar device is sold in the united states.The test strips were requested for investigation.No product has been returned.Relevant retention material roche cardiac d-dimer of lot 18710710 was measured on a cobas h232 instrument at the investigation site with: two native blood samples and two spiked blood samples (c=0.80 ¿g/ml and c=2.50 ¿g/ml).The mean of the measurements on the cobas h232 instrument at the investigation site: first native blood sample: 0.20 ¿g/ml.Second native blood sample: 0.18 ¿g/ml.First spiked blood sample (c=0.80 ¿g/ml): 0.85 ¿g/ml.Second spiked blood sample (c=2.50 ¿g/ml): 2.60 ¿g/ml.The results of all measurements fulfill the requirements.

Manufacturer Narrative

The customer has not returned any product.A specific root cause could not be identified for this event.Additional information was requested for investigation but was not provided.

• 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: 6605208
• MDR Text Key: 76508071
• Report Number: 1823260-2017-01125
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 06/20/2017

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: 10/31/2017
• Device Catalogue Number: 04877802190
• Device Lot Number: 18710710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• 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