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

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

The customer has reported that they have received questionable results for a total of four patients tested for roche cardiac d-dimer (ddi) on a cobas h232 meter when compared to the d-dimer method on a siemens ca 1500 instrument.Of the four patients, two had results that were erroneous.The first patient had a sample tested for ddi and it resulted as 0.41 ug/ml on (b)(6) 2014.The first patient also had another sample tested on the siemens ca 1500 instrument and it resulted as 1.3 mg/l feu for d- dimer on (b)(6) 2014.The second patient, a male born on (b)(6) 1943, had a sample tested for ddi and it resulted as 0.34 ug/ml on (b)(6) 2014.The second patient also had another sample tested on the siemens ca 1500 instrument and it resulted as 0.8 mg/l feu for d-dimer on (b)(6) 2014.The patients were not adversely affected.The serial number of the cobas h232 meter is ks0206555.This meter is not sold in the united states.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Retention materials were tested and the results of all measurements fulfill requirements.

Manufacturer Narrative

The customer's analyzer was provided for investigation.Retention materials were tested on the customer's analyzer and all measurements fulfill requirements.Test strips from the customer site were requested for investigation, but these could not be provided.

• Brand Name: 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) ASKU ; GM ASKU
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4330089
• MDR Text Key: 5212575
• Report Number: 1823260-2014-09966
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2015

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: Physician
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Examination Room
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2014; 01/27/2015
• 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
• Patient Age: 066 YR