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 Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable low cardiac d-dimer assay results for two patient sample from the cobas h232 meter serial number (b)(4).The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.On (b)(6) 2017, the result from the cobas h232 was 170 ug/l and the result from the sta analyzer was 2040 ug/l.On (b)(6) 2017, the result from the cobas h232 was 160 ug/l and the result from the sta analyzer was 2000 ug/l.Information concerning if any erroneous result was reported outside of the laboratory was requested, but it was unknown.There was no allegation of an adverse event.

Manufacturer Narrative

Upon follow up with the customer, they stated the issue was not with the roche device but was with the sta analyzer.

Manufacturer Narrative

Relevant retention material roche cardiac d-dimer of lot 22559510 was measured on qualified cobas h232 with: two native blood samples and two spiked blood samples (c=0.80 g/ml and c=2.2 g/ml), each blood sample n=three test strips.Mean of the measurements on qualified cobas h232: first native blood sample: 0.20 g/ml.Second native blood sample: 0.15 g/ml.First spiked blood sample (c=0.80 g/ml): 0.92 g/ml.Second spiked blood sample (c=2.2 g/ml): 2.00 g/ml.The results of all measurements fulfilled the 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: 7185416
• MDR Text Key: 97742466
• Report Number: 1823260-2018-00139
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 02/19/2018

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: 22559510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/03/2018; 01/03/2018
• Supplement Dates FDA Received: 01/29/2018; 02/19/2018
• 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