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

Catalog Number 04404483190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

Event Type  malfunction  

Event Description

The customer complained of a questionable gluc3 glucose hk gen.3 result for 1 lipemic patient sample tested on a cobas 6000 c (501) module.The initial gluc3 result was 449 mg/dl.The patient sample was tested on another cobas c501 analyzer with gluc3 result of 326 mg/dl.The patient sample was ultracentrifuged and tested on the original analyzer with a gluc3 result of 221 mg/dl.The customer also mentioned that the patient sample was tested on an istat instrument and using glucose strips with results between 220 - 230 mg/dl.No erroneous results were reported outside of the laboratory.The gluc3 result of 221 mg/dl was deemed to be correct.There was no adverse event.The cobas c501 serial number was (b)(4).The customer did not request service as they believed the issue was sample specific.The patient sample was noted to be milky and cloudy and was clearer after being ultracentrifuged.The initial centrifuge time of the patient sample was not within the sample tube manufacturers recommendations.Ultracentrifugation is also not an approved method in product labeling.On the day of the event, there were multiple abnormal probe sucking alarms.The patient sample was not available for further investigation and therefore a pre-analytical issue could not be verified.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
• 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: 8343129
• MDR Text Key: 136256347
• Report Number: 1823260-2019-00625
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 01/30/2019
• 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: 32 YR
• Patient Weight: 86