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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received a questionable roche cardiac d-dimer result from cobas h232 meter serial number (b)(4).The cobas h232 meter is not sold in the united states.The initial result was 0.69 mg/l.About one hour later, the same sample was tested on another cobas h232 meter using the same lot of test strips and the result was 1.40 mg/l.On(b)(6) 2015, the same patient was tested on both meters and the result from cobas h232 meter serial number (b)(4) was lower.No specific data was provided.Information concerning if any result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.The customer cleaned the meter.Relevant retention material was tested and all result fulfilled the requirements.

Manufacturer Narrative

The cobas h232 meter and two cardiac d-dimer test strips were sent by the customer for further investigation.All testing with the meter and strips fulfilled the requirements.The system is working according to specification.

• 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: 4996674
• MDR Text Key: 23258023
• Report Number: 1823260-2015-03951
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 08/21/2015

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: Health Professional
• Device Catalogue Number: 04877802190
• Device Lot Number: 282171110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• 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