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 Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for gluc3 glucose hk gen.3 (glu) on two cobas integra 400 plus (i400+) analyzers.An erroneous result was reported outside of the laboratory.The sample was measured several times on two i400+ analyzers and the results were approximately 6 to 7 mg/dl.The sample was measured with a glucometer and the results were approximately 97 to 107 mg/dl.The customer collected a new sample from the patient and repeated measurements on an i400+ analyzer.The customer measured different tubes of this sample consisting of different sample material (serum, plasma, serum collected from capillary blood).All results were comparable.It was asked, but it is not known if any adverse events occurred.No adverse events were alleged to have occurred with the patient.The serial numbers of the i400+ analyzers were asked for, but not provided.

Manufacturer Narrative

The patient sample was sent to another laboratory for testing with a different method, glucose dehydrogenase.The result was comparable to results obtained on the i400+ analyzers.The customer consulted the physician and determined that the low glucose values were probably due to high vitamin c supplementation of the patient or incorrect use of the glucometer.The customer noticed a tendency toward lower blood glucose levels of the patient over a period of time, but there were no symptoms of hypoglycemia.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.No further events have been reported by the customer since the event.No explicit issues could be found with the reagent or analyzer.A customer handling issue may have caused the event.

• Brand Name: GLUC3 GLUCOSE HK GEN.3
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6968329
• MDR Text Key: 90797642
• Report Number: 1823260-2017-02396
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04404483190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1