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 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer has not run any d-dimer controls on the meter.Relevant retention materials (strip lot 39451710) were measured on qualified cobas h232 with one native blood sample and two spiked blood samples results: native blood sample: 0.31 ¿g/ml; first spiked blood sample (target=0.7 ¿g/ml): 0.72 ¿g/ml; second spiked blood sample (target=1.1 ¿g/ml): 1.22 ¿g/ml.Native blood sample: 0.29 ¿g/ml; first spiked blood sample (target=0.7 ¿g/ml): 0.71 ¿g/ml; second spiked blood sample (target=1.1 ¿g/ml): 1.26 ¿g/ml.The measurements results with relevant retention material and qualified cobas h232 fulfill were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.The event occurred in: (b)(6).

Event Description

The customer complained of a questionable roche cardiac d-dimer 10 tests (cobas) result for 1 patient tested on a cobas h 232 meter serial number (b)(4) compared to an abbott system using a photometric/immunochemistry method.The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.The patient's d-dimer result from the cobas h232 meter was < 0.10 mg/l while the result from the laboratory was 1.10 mg/l.The samples were taken at the same time but were collected into two separate tubes.The result in question was not reported outside of the laboratory.

• 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: 8875140
• MDR Text Key: 153828347
• Report Number: 1823260-2019-02911
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 08/08/2019

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 04877802190
• Device Lot Number: 39451711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/08/2019
• 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