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 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

A patient arrived at the emergency room with symptoms of hyperglycemia after obtaining a higher than expected glucose reading on her home meter (type unknown).The customer then obtained questionable low glucose results for the patient using the gluc3 glucose hk gen.3 on the cobas 6000 c (501) module (c501, serial number (b)(4)).The initial results were released outside the laboratory.No data flags or alarms occurred.All results are in units of mg/dl.At 7:23 am, a venous sample result was 106 on the c501; sample was repeated at an unknown time with a result of 107.At 10:22 am, a venous sample result was 144 on the c501.At 5:00 pm, a fingerstick sample result was 499 from a professional glucose meter (type not provided).At 6:20 pm, a fingerstick sample result was 405 from the professional glucose meter.At 6:28 pm, a fingerstick sample result was 355 from the professional glucose meter.At 6:29 pm, a venous sample result was 88 on the c501.The customer did not believe the results from the c501.The patient was treated for hyperglycemia based upon the meter results.The customer recalibrated the assay after the event and ran quality controls (qc) which were acceptable.The customer repeated the venous sample from 6:29 pm on the original c501 and another c501.The results were 89 and 91 respectively.No adverse event occurred.The patient ingested 50 grams of vitamin c at some point prior to the sample draws.The customer suspected possible interference.Calibration and qc were acceptable prior to the event.The field service representative did not find a cause for the issue.He adjusted the gear pump pressure and flushed two valves.He checked dispense levels.The customer ran a precision check which was acceptable.Samples were requested for investigation.Investigation activities are ongoing.

Manufacturer Narrative

It was clarified that the vitamin c was administered to the patient via iv 3 hours prior to the initial sample draw.It was noted that ascorbic acid shows no interference un to 300 mg/l on the c501 module.The customer sent the venous samples that had been tested on the c501 module out to an external laboratory using the beckman coulter method.The exact results from the beckman coulter method are not available, however the results were comparable to the initial results from the c501 module.The investigation stated there was no risk to the patient since the patient was tested on a professional point of care device where high results were confirmed and the appropriate treatment was provided.A general reagent or hardware issue has been excluded since calibration and quality controls were acceptable.The patient was on 13 different medications including vitamin c at the time of the initial result.A potential root cause may be related to an interference caused by the mix of medications.The investigation is ongoing.

Manufacturer Narrative

A specific root cause was not identified for this event.The customer will not be providing any additional details related to the event.Since the patient sample is not available, the investigation could not be completed.

• 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: 6813290
• MDR Text Key: 83747086
• Report Number: 1823260-2017-01803
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 04404483190
• Device Lot Number: 21726101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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
• Patient Age: 53 YR