MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC D-DIMER; FIBRINOGEN/FIBRIN DEGREDATION PRODUCTS ASSAY

Catalog Number 12241528196

Device Problem High Test Results (2457)

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

Event Date 03/20/2014

Event Type  malfunction  

Event Description

The customer complained of a questionable result for one patient sample tested with the roche cardiac d-dimer (ddi) test.The test was performed on cardiac reader, serial number (b)(4).The initial ddi result was 1.2 ug/ml.The test was repeated twice with results of 0.78 and 0.92 ug/ml.The customer would only state the test was reported outside the laboratory as "positive." the specific date of testing was requested, but the customer would not provide the information.There were no adverse events.The lot number and expiration date of the test strips were requested but were not provided by the customer.

Manufacturer Narrative

The event took place in (b)(6).

Manufacturer Narrative

A root cause could not be identified.No products were returned for investigation.Additional information needed for further investigation was requested but not provided.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN/FIBRIN DEGREDATION PRODUCTS ASSAY
• 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: 3716622
• MDR Text Key: 4229886
• Report Number: 1823260-2014-02245
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

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: 12241528196
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2014
• 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