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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable d-dimer results for one patient sample from cobas h232 meter serial number (b)(4).The cobas h232 meter or a similar product is not sold in the united states.The specific date of testing was not known.The initial result was 3.5 ug/ml.Due to the high result, they took another sample from the patient and the result was 3.59 ug/ml.The results were reported outside the laboratory.The patient was then hospitalized where a new sample was taken a few hours later and the result was below 1 ug/ml on an analyzer from "(b)(6) using a immunometric method with monoclonal antibodies".No adverse event was reported.

Manufacturer Narrative

The result for the sample taken from the patient at the hospital that was initially reported as "below 1 ug/ml" was actually 0.7 ug/ml.

Manufacturer Narrative

A specific root cause could not be identified.The customer's h232 meter was submitted for investigation and testing was performed with relevant retention material.The results of all measurements fulfilled the requirements.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5049473
• MDR Text Key: 24942900
• Report Number: 1823260-2015-04075
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/17/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1