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 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable roche cardiac d-dimer 10 tests (cobas) results from cobas h 232 meter serial number (b)(4).The customer provided 7 patient results of which 4 were a reportable malfunction.The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.Refer to the attachment for patient data.The units of measurements were not clear but clarification has been requested.There was no allegation of an adverse event.It was unclear if the erroneous results were reported outside of the laboratory but clarification has been requested.Liquid controls and internal qc results were acceptable.The meter and test strips have been requested for further investigation.

Manufacturer Narrative

The customer clarified that no erroneous results were reported outside of the laboratory.The units of measure were g/ml.

Manufacturer Narrative

The customer returned the h232 meter for investigation.Routine retention testing of master lot roche cardiac d-dimer #17339780 was used for measurement on the customer¿s returned meter and a retention h232 meter with 1 native sample and 2 spiked samples.The results of these measurements were acceptable.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: 8109751
• MDR Text Key: 129327545
• Report Number: 1823260-2018-04503
• 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,Followup
• Report Date: 03/27/2019

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 Catalogue Number: 04877802190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 11/07/2018; 11/07/2018
• Supplement Dates FDA Received: 12/03/2018; 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1