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 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

It was reported that the customer received erroneous results for two samples from the same patient tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer.The erroneous results were reported outside of the laboratory.The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states.The first sample resulted as 0.34 ug/ml when tested on the cobas h 232 analyzer.The sample was also tested at another laboratory using a biomajesty 6030 analyzer using the ns auto d-dimer test method, where it resulted as 235 ug/ml.The second sample resulted as 0.32 ug/ml when tested on the cobas h 232 analyzer on (b)(6) 2016.The sample was also tested at another laboratory using a biomajesty 6030 analyzer using the ns auto d-dimer test method, where it resulted as 55 ug/ml.A cobas h 232 d-dimer result of 0.34 ug/ml from (b)(6) 2016 and a d-dimer result of 243 ug/ml from an outsourced laboratory were also provided, but it was not clear if these were results from a different sample or if the data represents the same results from the first or second sample.It was stated that the result from the outsourced lab was believed to be correct since it aligned with the patient's clinical condition.The patient was not adversely affected.The cobas h 232 analyzer serial number was (b)(4).A specific root cause could not be determined based on the provided information.Materials were requested from the customer for investigation, but were not provided.Measurements performed with retention materials fulfill requirements.No irregularities were seen with the retention material.

• 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: 5508104
• MDR Text Key: 40645851
• Report Number: 1823260-2016-00317
• Device Sequence Number: 1
• Product Code: DAP
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 04877802190
• Device Lot Number: 28231310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• 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