MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3 GLUCOSE HK GEN.3; HEXOKINASE, GLUCOSE

Catalog Number 04404483190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Event Description

The customer complained of questionable gluc3 glucose hk gen.3 results for 1 patient tested on a cobas 6000 c (501) module that are not fitting the patient's clinical picture.The customer stated that the questionable results have been obtained from two separate blood draws.The initial blood draw was on (b)(6) 2018 and a second blood draw was done on (b)(6) 2018.The gluc3 results from the (b)(6) 2018 blood draw were not provided, but it was stated by the customer that the results were similar to the gluc3 results from the sample on (b)(6) 2018.The gluc3 results from (b)(6) 2018 were released to the physician and were the reason why a second sample was collected on (b)(6) 2018.On (b)(6) 2018 the initial gluc3 result was 40 mg/dl with a data flag and the repeat result was 36 mg/dl with a data flag.The patient had a fingerstick glucose result of 98 mg/dl and from a sample that was collected in a lavender top tube (k2 edta) a gluc3 result of 102 mg/dl was obtained.It was unknown which glucose result was deemed to be correct.There was no adverse event.The cobas c501 serial number was (b)(4).It was stated that all other basic metabolic panel results for the patient were normal.The investigation is currently ongoing.

Manufacturer Narrative

The qc data provided gave no indication of a performance issue with the reagent or the instrument.Service was not able to determine a cause of the event.The issue was an isolated event and there have been no other problems with patient data or qc.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: GLUC3 GLUCOSE HK GEN.3
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8178410
• MDR Text Key: 131145749
• Report Number: 1823260-2018-04976
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 04404483190
• Device Lot Number: 34296901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN 200 MG; METHOCARBAMOL 750 MG; PREDNISONE 10 MG
• Patient Age: 56 YR