MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC2 GLUCOSE HK; HEXOKINASE, GLUCOSE

Catalog Number 20767131322

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone was provided as (b)(6).

Event Description

The customer received questionable low gluc3 glucose hk gen.2 results for one patient from two cobas 6000 c501 modules.Only one serial number ((b)(4)) was provided.The patient was not responsive at the dentist and when the ambulance arrived, the patient became responsive again but was taken to hospital.At the hospital, for the first sample the glucose results from two different cobas 6000 analyzers were 11 mg/dl and 4 mg/dl.The result from a bga system for a different tube from for the same draw was 90 mg/dl.For a second sample, the glucose results from two different cobas 6000 analyzers were 47 mg/dl and 43 mg/dl.The result from a bga system for a different tube from for the same draw was 102 mg/dl.The result from a poct- bz system was 89 mg/dl.For a third sample, the glucose results from two different cobas 6000 analyzers 93 mg/dl and 95 mg/dl.All of the results were reported outside of the laboratory.The patient was not adversely affected.

Manufacturer Narrative

The bga system is from radiometer, the poct system is from nova medical.Samples were requested for investigation.Two of the samples were centrifuged prior to the investigation due to turbidity.The investigation results were comparable to the customer¿s c501 results.The investigation is ongoing.

Manufacturer Narrative

The samples contained igm above the reference range.The event is consistent with an interference due to immunoglobulins.This interference is covered in product labeling.

• Brand Name: GLUC2 GLUCOSE HK
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8045772
• MDR Text Key: 128259801
• Report Number: 1823260-2018-04120
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• PMA/PMN Number: K061048
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20767131322
• Device Lot Number: 336546
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RAMIPRIL
• Patient Age: 73 YR