MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-CHOLESTEROL GEN.4; HIGH DENSITY LIPOPROTEIN TEST SYSTEM

Model Number HDL-C G4

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained that for 1 patient an interferant is affecting the patient's chol2 cholesterol gen.2, hdlc4 hdl-cholesterol plus 4th generation, and ldl_c ldl-cholesterol plus 3rd generation results from a cobas 8000 c702 module.This medwatch will cover hdlc4.For information on chol2 refer to the medwatch with patient identifier (b)(6) and for ldl_c refer to the medwatch with patient identifier (b)(6).The specific data has been requested but has not been provided.The customer stated that the chol2 results were too high and the hdlc4 and ldl_c results were too low.The results in question have been reported to the clinicians.The cobas 8000 c702 module serial number is (b)(4).

Manufacturer Narrative

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

• Brand Name: HDL-CHOLESTEROL GEN.4
• Type of Device: HIGH DENSITY LIPOPROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8860763
• MDR Text Key: 153813839
• Report Number: 1823260-2019-02834
• Device Sequence Number: 1
• Product Code: LBS
• Combination Product (y/n): N
• PMA/PMN Number: K162593
• 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: 08/21/2019

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 Model Number: HDL-C G4
• Device Catalogue Number: 07528582190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1