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

Catalog Number 04877802190

Device Problem High Test Results (2457)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 2 patient samples tested for roche cardiac d-dimer on an h232 meter.Both patients were sent to the hospital following the test from the meter.A new blood sample was obtained and both were tested at the laboratory.The results from both the h232 meter and the laboratory were reported to physicians.On (b)(6) 2015 patient 1 initial roche cardiac d-dimer result was 1.1 ug/ml ug/ml at 1:00 p.M.The patient was sent to the emergency room of the hospital where a new blood sample was obtained.The result from the laboratory at 5:00 p.M.Was 0.37 ug/ml.On (b)(6) 2015 patient 2 (male) initial roche cardiac d-dimer result was 2.0 ug/ml at 12:00 p.M.The patient was sent to the emergency room of the hospital where a new blood sample was obtained.The result from the laboratory at 3:20 p.M.Was 0.68 ug/ml.No adverse event for either patient has been reported.Quality controls were acceptable.The h232 serial number was (b)(4).Neither the h232 nor a similar device is sold in the united states.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Retention samples of the same lot that customer used were tested.The results of all measurements fulfill requirements.

Manufacturer Narrative

The customer returned the h232 instrument with serial number (b)(4).No test strips were provided for investigation.Retention samples of the same lot that customer used were tested on customer's instrument as well as the h232 instrument used during the investigation.The results of all measurements on the customer's h232 and on the h232 used during the investigation fulfill our requirements.A root cause for the event could not be determined.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4882900
• MDR Text Key: 6042389
• Report Number: 1823260-2015-03743
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: 28207015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/17/2015
• 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
• Patient Sequence Number: 1
• Treatment: PATIENT 2 - OXYNORM; PATIENT 2 - SIMVASTATIN; PATIENT 2 - PREDNISONE; PATIENT 1 - NOT PROVIDED; PATIENT 2 - AZATHIOPRINE; PATIENT 2 - BISOPROPOL