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 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device was requested to be returned for investigation.Relevant retention material roche cardiac d-dimer of lot 38034310 was measured on a qualified cobas h232 with three spiked blood samples in comparison with the master lot 17339780.First spiked blood sample: 0.45 ¿g/ml, second spiked blood sample: 0.72 ¿g/ml, third spiked blood sample: 1.48 ¿g/ml.Results: mean of the measurements with master lot on qualified cobas h232: first spiked blood sample: 0.49 ¿g/ml, second spiked blood sample: 0.71 ¿g/ml, third spiked blood sample: 1.47 ¿g/ml.The measurements results with relevant retention material on qualified cobas h232 were acceptable.The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of a questionable roche cardiac d-dimer result from a cobas h 232 meter serial number (b)(4) compared to the laboratory result.The cobas h 232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.The laboratory reagent and method were not provided.The d-dimer result from the h 232 meter was 480 ug/ml.The d-dimer result from the laboratory was 1100 ug/ml.No questionable results were reported outside of the laboratory.There was no allegation of an adverse event.The qc was acceptable.

Manufacturer Narrative

The customer returned cobas h232 serial number (b)(4).And one box of roche cardiac d-dimer containing 2 strips for investigation.No visual abnormalities were noted.A qualified cobas h232 and the master lot test strips along with the customer returned material were used to measure one native blood sample and 2 spiked blood samples.The measurement results fulfilled our requirements and there no measurement deviations were observed.The investigation did not identify a product problem.

• 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
• MDR Report Key: 8758504
• MDR Text Key: 150138771
• Report Number: 1823260-2019-02434
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 04877802190
• Device Lot Number: 38034311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1