MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received discrepant results for six patient samples tested with d-di tina-quant d-dimer gen.2 on a cobas integra 400 plus analyzer.The results measured on the integra 400 plus were higher compared to values measured on a cobas h 232 meter.The cobas h 232 meter and associated products are not released for distribution in the united states.The first patient sample resulted with a d-dimer value of 0.63 ug/ml when tested on the integra and resulted with a value of 0.45 ug/ml when tested on the cobas h 232.On (b)(6) 2020, the second patient sample resulted with a d-dimer value of 7.15 ug/ml when tested on the integra and resulted with a value of 3.4 ug/ml when tested on the cobas h 232.On (b)(6) 2020, the third patient sample resulted with a d-dimer value of 36.52 ug/ml when tested on the integra and resulted with a value of 0.83 ug/ml when tested on the cobas h 232.On (b)(6) 2020, the fourth patient sample resulted with a d-dimer value of 32 ug/ml when tested on the integra and resulted with a value of 0.8 ug/ml when tested on the cobas h 232.On (b)(6) 2020, the fifth patient sample resulted with a d-dimer value of 2.64 ug/ml when tested on the integra and resulted with a value of 1.45 ug/ml when tested on the cobas h 232.On (b)(6) 2020, the sixth patient sample resulted with a d-dimer value of 2.64 ug/ml when tested on the integra and resulted with a value of 1.2 ug/ml when tested on the cobas h 232.The serial number of the integra 400 plus analyzer is (b)(4).

• Brand Name: D-DIMER
• Type of Device: 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: 10009444
• MDR Text Key: 216183936
• Report Number: 1823260-2020-01138
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062203
• 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: 04/29/2020

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: 04912551190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/29/2020
• 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