MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; FIBRINOGEN AND FIBRIN SPLIT PRODUCTS

Catalog Number 04877802190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for roche cardiac d-dimer on an h232 instrument.The initial d-dimer result was 0.12 ug/ml.Approximately 1 hour later, the customer ran the sample again and the result was 3.12 ug/ml.The customer only reported the 3.12 ug/ml result to the physician.The customer has been using the h232 instrument for 2 years.On (b)(6) 2017 the field service engineer (fse) ran instrument verification and the quality control results were acceptable.There was no allegation that an adverse event occurred.The h 232 instrument serial number was (b)(4).Neither the h232 instrument nor a similar device is sold in the united states.The meter and strips were requested for investigation.Relevant retention material (roche cardiac d-dimer of lot 19752510) was measured on a cobas h232 used at the investigation site with: two native blood samples and one spiked blood.Sample (c=3.00 ¿g/ml), each blood sample n= three test strips.The mean of the measurements on the cobas h232 used at the investigation site: first native blood sample: 0.12 ¿g/ml, second native blood sample: 0.21 ¿g/ml, spiked blood sample (c=3.00 ¿g/ml): 2.80 ¿g/ml.The results of all measurements fulfill the requirements.

Manufacturer Narrative

The customer has not returned any product.A specific root cause was not 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: 6613817
• MDR Text Key: 76748189
• Report Number: 1823260-2017-01156
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: HO
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 04877802190
• Device Lot Number: 19752511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• 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