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 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer.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.There were no other issues with unexpected results or issues with sample errors.The patient had no known interferences.Two samples were collected from the patient at the same time.One sample was tested on the cobas h 232 analyzer, resulting with a ddi value of 0.33 ug/ml.The second sample was tested using an unknown laboratory method, resulting with a ddi value of 2.31 ug/ml.The results were reported outside of the laboratory to nurses, who advised the patient.The nurses then called about the event.The patient was not adversely affected.The cobas h 232 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be determined as the customer material was requested, but not returned.Investigations were performed on retention material from the same lot number.Relevant retention material 14008810 was measured on a cobas h232 analyzers with two native blood samples and two spiked blood samples.Each blood sample was tested three times.The results were as follows: mean of the measurements: first native blood sample: 0.23 ug/ml.Second native blood sample: 0.19 ug/ml.First spiked blood sample (c=0.70 ug/ml): 0.74 ug/ml.Second spiked blood sample (c=2.20 ug/ml): 2.10 ¿u/ml.All measurements performed with this material fulfilled 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 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: 5939615
• MDR Text Key: 54348243
• Report Number: 1823260-2016-01341
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

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: 14008810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• 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