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 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Customer does not intend to send any material in for investigation.

Event Description

The customer complained of erroneous results for 1 patient tested for roche cardiac d-dimer on the h232 instrument used in a hospital.The initial roche cardiac d-dimer result on the h232 instrument was 0.71 ug/ml.The repeat result was 1.3 ug/ml.A fibrin degradation products (fdp) test on a sysmex ca1500 instrument was 280 ug/ml.Based on the result from the sysmex ca1500 instrument the customer questioned the low results from the h232 instrument.The customer wonders if the results from the h232 instrument are due to a hook effect.No adverse event occurred.The h232 instrument serial number was (b)(4).Neither the h232 instrument nor a similar device is sold in the united states.The customer is not requesting any further support and has declined to send any material in to complete the investigation.

• 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: 5637458
• MDR Text Key: 44684879
• Report Number: 1823260-2016-00610
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial
• Report Date: 05/06/2016

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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/06/2016
• 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