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 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received erroneous results for three patient samples tested for roche cardiac d-dimer on a cobas h 232 analyzer.The results were low when compared to laboratory test results.The patients had no deep vein thrombosis or pulmonary embolism.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, from a patient born in (b)(6), resulted as 0.36 ug/ml.The patient also had a sample tested in the hospital laboratory, resulting as 3.4 ug/ml.The patient results were reported outside of the laboratory.The second sample, from a male patient born in (b)(6), resulted as 0.30 ug/ml.The patient also had a sample tested in the hospital laboratory, resulting as 1.1 ug/ml.The patient results were reported outside of the laboratory.The third sample, from a male patient born in (b)(6), resulted as 0.45 ug/ml.The patient also had a sample tested in the hospital laboratory, resulting as 1 ug/ml.The patient results were reported outside of the laboratory.The patients were hospitalized and received medical intervention based on the erroneous results.No details were provided on the medical intervention received.The patients were not adversely affected.The cobas h 232 analyzer serial number was (b)(4).

Manufacturer Narrative

The customer provided their cobas h 232 analyzer and test strips for investigation.Investigation measurements performed with retention materials and the customer materials fulfilled all requirements.

• 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
• 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: 5331542
• MDR Text Key: 34531093
• Report Number: 1823260-2015-06135
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 04877802190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• 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