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

Catalog Number 05168791190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

The customer stated that they have sporadically been getting low results for an unspecified number of patient samples tested with gluc3 glucose hk gen.3 on a cobas 8000 c 702 module.Some samples will have results of 18, 5, or 2.When repeated, these samples have normal results.The customer provided a specific example for one patient sample with an erroneous result.No erroneous results were reported outside of the laboratory.The unit of measure used for gluc3 was not provided.The sample initially resulted with a value of 18, which repeated around 100.No adverse events were alleged to have occurred with the patient.The serial number of the c 702 module is (b)(4).Quality controls were acceptable.The customer declined a service visit.The customer replaced the reagent pack and stated that the issue was resolved.The investigation could 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: 8249418
• MDR Text Key: 133198114
• Report Number: 1823260-2019-00201
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168791190
• Device Lot Number: 342842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• 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